Compositions supporting and promoting the function of the nervous system

Abstract

The present invention relates to compositions and combinations of substances for supporting and promoting the function of the nervous system. In particular, the present invention relates to the treatment and / or prevention of neurological disorders, neuropsychiatric disorders and psychiatric disorders. In view thereof, the present invention provides combinations and compositions, comprising a number of specific compounds with a beneficial effect on the nervous system.

Description

[0001] Compositions supporting and promoting the function of the nervous system

[0002] FIELD OF INVENTION

[0003] The present invention relates to compositions and combinations of substances for supporting and promoting the function of the nervous system. In particular, the present invention relates to the treatment and / or prevention of neurological disorders, neuropsychiatric disorders and psychiatric disorders. In view thereof, the present invention provides combinations and compositions, comprising a number of specific compounds with a beneficial effect on the nervous system.

[0004] BACKGROUND OF THE INVENTION

[0005] Hundreds of millions of people globally are affected by disorders of the nervous system, in particular neurological, neurodevelopmental and psychiatric disorders. Neurological disorders comprise, but are not limited to: headache, epilepsy, stroke, brain inflammation, such as brain infection, and neurodegenerative disease, such as Alzheimer's disease, Parkinson's disease and multiple sclerosis. Neurodevelopmental disorders comprise, but are not limited to: autism spectrum disorder and tic disorder, such as Tourette Syndrome. Psychiatric disorders comprise, but are not limited to: depression, anxiety and schizophrenia. According to the estimates of the World Health Organization for the year 2023, more than 55 million people worldwide are affected by dementia, about 1 in 100 children has autism spectrum disorder, and approximately 5% of adults suffer from depression.

[0006] Various processes, which are indispensable for the normal function of the nervous system, are disturbed in individuals suffering from by neurological, neurodevelopmental and psychiatric disorders. The most important disturbances comprise, but are not limited to: neuronal damage caused by abundant presence of free radicals, combined with reduced antioxidant capacity; accumulation of toxic compounds, such as heavy metals; neuro-inflammation, amongst others due to infective agents; impaired mitochondrial function, resulting in insufficient energy production; aggregation of damaged proteins and formation of plaques, such as beta-amyloid, tau protein, and alpha-synuclein; impaired gene function; impaired production and function of neurotransmitters; and impaired neuronal conduction and synaptic transmission.

[0007] As it is known to those skilled in the art, treatment of neurological, neurodevelopmental and psychiatric disorders is challenging, and the efficacy of existing therapeutical options is oftentimes limited. In particular, most treatments lack a comprehensive support, recovery and enhancement of the function of the nervous system, enabling it to simultaneously deal with multiple elements of the mentioned disturbances.

[0008] In view of the high prevalence of neurological, neurodevelopmental and psychiatric disorders, and limited therapeutic and prophylactic treatment options for disturbed processes in the nervous system, there is a need for alternative and improved approaches and therapies.

[0009] SUMMARY OF THE INVENTION

[0010] The inventor has found that the combination of multiple specific substances is surprisingly effective to support and promote the nervous system. Therefore, in a particular embodiment, the present invention provides a composition comprising: vitamin Bl; vitamin B2; vitamin B3; vitamin B5; vitamin B6; vitamin B8; vitamin B9; vitamin B12; vitamin E; choline; myo-inositol; coenzyme Q10 ; garlic extract; sulforaphane; carnitine; curcumin; resveratrol; and betaine.

[0011] In a further embodiment, the present invention provides a composition wherein sulforaphane is comprised in a broccoli extract; curcumin is comprised in a curcuma extract; and resveratrol is comprised in a Japanese knotweed extract.

[0012] In another particular embodiment, the present invention provides a composition comprising: vitamin Bl in an amount of 0.50 to 3.00 wt. %; vitamin B2 in an amount of 0.50 to 3.00 wt. %; vitamin B3 in an amount of 0.50 to 3.00 wt. %; vitamin B5 in an amount of 2.00 to 4.00 wt. %; vitamin B6 in an amount of 0.10 to 0.60 wt. %; vitamin B8 (biotin) in an amount of 0.005 to 0.03 wt. %; vitamin B9 (folic acid) in an amount of 0.02 to 0.04 wt. %; vitamin B12 in an amount of 0.02 to 0.04 wt. %; vitamin E in an amount of 0.50 to 3.00 wt. %; choline in an amount of 15.00 to 20.00 wt. %; myo-inositol in an amount of 0.50 to 3.00 wt. %; coenzyme Q10 in an amount of 2.00 to 4.00 wt. %; garlic extract in an amount of 12.00 to 17.00 wt. %; broccoli extract in an amount of 12.00 to 17.00 wt. %; carnitine in an amount of 20.00 to 40.00 wt. %; curcuma extract in an amount of 2.00 to 4.00 wt. %;

[0013] Japanese knotweed extract in an amount of 2.00 to 4.00 wt. %; and betaine in an amount of 4.00 to 8.00 wt. %; wherein the wt. % is expressed as a wt. % over the total amount of substances a to r.

[0014] In a further embodiment, carnitine is acetyl-L-carnitine.

[0015] In another particular embodiment, the composition of the invention is a pharmaceutical composition, further comprising a pharmaceutically acceptable carrier. In yet another particular embodiment, the composition of the invention is a nutritional supplement.

[0016] The composition of the invention may be combined with other compositions. Therefore, in a particular embodiment, the present invention provides a combination of the composition as described herein with one or more substances selected from the group consisting of Siberian ginseng root extract, rhodiola extract, maca extract, ashwagandha extract, Schisandra berry extract, vitamin A, vitamin C, vitamin D3, Vitamin K2, zinc, selenium, manganese, molybdenum, boron, chromium, iodine, beta-carotene, lutein, zeaxanthin, lycopene, citrus flavonoids, alpha- lipoic acid, flaxseed oil, algae oil, chia seed oil, echium seed oil, ahiflower oil, blackcurrant seed oil, olive tree extract, grape seed extract, and astaxanthin. In one particular further embodiment, the present invention provides a combination of the composition as described herein with one or more substances selected from the group consisting of Siberian ginseng root extract, rhodiola extract, maca extract, ashwagandha extract, and Schisandra berry extract. In another further embodiment, the present invention provides a combination of the composition as described herein with one or more substances selected from the group consisting of vitamin A, vitamin C, vitamin D3, Vitamin K2, zinc, selenium, manganese, molybdenum, boron, chromium, iodine, beta-carotene, lutein, zeaxanthin, lycopene, citrus flavonoids, and alpha-lipoic acid. In yet another further embodiment, the present invention provides a combination of the composition as described herein with one or more substances selected from the group consisting of flaxseed oil, algae oil, chia seed oil, echium seed oil, ahiflower oil, blackcurrant seed oil, olive tree extract, grape seed extract, and astaxanthin. It is of particular interest to combine the composition of the invention with one or more substances selected from the group consisting of vitamin A, vitamin C, vitamin D3, Vitamin K2, zinc, selenium, manganese, molybdenum, boron, chromium, iodine, beta-carotene, lutein, zeaxanthin, lycopene, citrus flavonoids, and alpha-lipoic acid; particularly with at least 6, 7 or 8 of the substances; preferably with all of vitamin A, vitamin C, vitamin D3, Vitamin K2, zinc, selenium, manganese, molybdenum, boron, chromium, iodine, beta-carotene, lutein, zeaxanthin, lycopene, citrus flavonoids, and alpha-lipoic acid.

[0017] The present invention furthermore provides the compositions or the combinations described herein for use as a medicine. More in particular, the present invention provides the compositions or the combinations described herein for use in supporting and / or promoting the function of the nervous system; such as the central nervous system. Supporting and promoting the function of the nervous system may comprise treatment and / or prevention of one or more disorders selected from the group consisting of a neurological disorder, a neurodevelopmental disorder and a psychiatric disorder. In a particular further embodiment, the compositions and combinations of the invention are provided for use in the treatment and / or prevention of: a neurological disorder selected from the group consisting of headache, epilepsy, stroke, brain inflammation, such as brain infection, and neurodegenerative disease, such as Alzheimer's disease, Parkinson's disease, and multiple sclerosis; a neurodevelopmental disorder selected from the group consisting of autism spectrum disorder, and tic disorder, such as Tourette Syndrome; a psychiatric disorder selected from the group consisting of depression, anxiety, and schizophrenia.

[0018] In another particular embodiment, the compositions and combinations of the invention are provided for use in the treatment and / or prevention of a mammal, preferably a human. Therefore, the subject as described herein preferably is a human subject. Administration may be effected by various means, but preferably administration is oral.

[0019] In a particular embodiment, treatment and / or prevention comprises administration of the composition in a dose of 300 mg to 2000 mg per day.

[0020] Of particular interest is the provision of a composition for use in the treatment and / or prevention of one or more disorders selected from the group consisting of migraine, autism spectrum disorder, and Tourette Syndrome in a human subject, wherein the treatment / and or prevention comprises oral administration of the composition, and wherein administration of the composition results in a daily dose of: vitamin Bl in an amount of 20 to 35 mg; vitamin B2 in an amount of 20 to 40 mg; vitamin B3 in an amount of 15 to 30 mg; vitamin B5 in an amount of 25 to 75 mg; vitamin B6 in an amount of 1 to 8 mg; vitamin B8 in an amount of 0.05 to 0.3 mg; vitamin B9 in an amount of 0.2 to 0.6 mg; vitamin B12 in an amount of 0.2 to 0.6 mg; vitamin E in an amount of 15 to 50 mg; choline in an amount of 80 to 180 mg; myo-inositol in an amount of 15 to 40 mg; coenzyme Q10 in an amount of 30 to 200 mg; garlic extract in an amount of 100 to 300 mg; broccoli extract in an amount of 100 to 300 mg; carnitine in an amount of 250 to 750 mg; curcuma extract in an amount of 25 to 100 mg;

[0021] Japanese knotweed extract in an amount of 20 to 100 mg; and betaine in an amount of 25 to 150 mg.

[0022] In a preferred embodiment, the composition of the invention is provided as a unitary dose, preferably as a capsule. The unitary dose preferably comprises: vitamin Bl in an amount of 5 to 35 mg; vitamin B2 in an amount of 4 to 40 mg; vitamin B3 in an amount of 3.75 to 30 mg; vitamin B5 in an amount of 6.25 to 75 mg; vitamin B6 in an amount of 0.25 to 8 mg; vitamin B8 in an amount of 0.012 to 0.3 mg; vitamin B9 in an amount of 0.05 to 0.6 mg; vitamin B12 in an amount of 0.05 to 0.6 mg; vitamin E in an amount of 3.75 to 50 mg; choline in an amount of 20 to 180 mg; myo-inositol in an amount of 3.75 to 40 mg; coenzyme Q10 in an amount of 7.5 to 200 mg; garlic extract in an amount of 25 to 300 mg; broccoli extract in an amount of 25 to 300 mg; carnitine in an amount of 62.5 to 750 mg; curcuma extract in an amount of 6.25 to 100 mg; Japanese knotweed extract in an amount of 4 to 100 mg; and betaine in an amount of 6.25 to 150 mg.

[0023] DETAILED DESCRIPTION OF THE INVENTION

[0024] As described above, the present inventors have identified that compositions and combinations according to the invention enable supporting and / or promoting of the function of the nervous system, in particular treatment and / or prevention of disorders of the nervous system.

[0025] Definitions

[0026] As used herein, the term "Vitamin B complex" refers to a composition comprising at least three B vitamins, preferably comprising eight B vitamins, in particular vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B8 (also known as biotin), vitamin B9 (also known as folic acid) and vitamin B12.

[0027] The terms "substance", "ingredient", and "compound" are used interchangeably, and refer to any substance, which may be used as a constituent of a composition or of a combination within the context of the current invention.

[0028] As used herein, the terms "treatment," "treating," and the like, refer to obtaining a desired pharmacologic and / or physiologic effect. The effect may be prophylactic in terms of completely or partially preventing a disease or a symptom thereof and / or may be therapeutic in terms of a partial or complete cure for a disease and / or adverse effect attributable to the disease. "Treatment," as used herein, covers any treatment of a disease in a living organism, particularly in a human, and includes: (a) preventing the disease from occurring in a subject which may be predisposed to it; (b) inhibiting the disease, i.e. arresting its development; (c) relieving the disease, i.e., causing regression of the disease; and (d) preventing complications and sequels of the disease, including development or aggravation of a secondary disease.

[0029] As used herein, the term "subject", refers to any living organism which has a nervous system. The subject may be of any age, immunocompetent or immunocompromised. The subject may be symptomatic or asymptomatic.

[0030] As used herein, the term "pharmaceutically acceptable carrier" refers to any material which, when combined with an active ingredient, allows the ingredient to retain biological activity - in particular, any material which enhances or stabilizes the composition or can be used to facilitate preparation of the composition.

[0031] As used herein, the term "nutritional supplement" refers to any composition, which is suitable to be added to nutrition or can be ingested by itself. Therefore, a nutritional supplement exclusively comprises ingredients, which can be safely ingested by a subject.

[0032] As used herein, the terms "comprising" and "including" are inclusive or open-ended and do not exclude additional unrecited elements, compositional ingredients, or method steps. Accordingly, the terms "comprising" and "including" encompass the more restrictive terms "consisting essentially of" and "consisting of".

[0033] Function of the nervous system

[0034] The nervous system comprises the central and peripheral nervous system. The central nervous system comprises the brain and the spinal cord; the peripheral nervous system is everything else.

[0035] In a nutshell, the nervous system is a framework that connects and integrates the different body parts with each other. The central nervous system's functions comprise receiving, processing, and responding to sensory information. The brain functions as an organ of nervous tissue that is responsible for responses, sensation, movement, emotions, communication, thought processing, and memory. The spinal cord sends motor commands from the brain to the peripheral body as well as to relays sensory information from the sensory organs to the brain. The peripheral nervous system relays the information between the central nervous system and the peripheral body.

[0036] The nervous system controls amongst others growth and development; sensations (such as touch or hearing); perception (the mental process of interpreting sensory information); thought and emotions; learning and memory; movement, balance, and coordination; sleep; healing and rehabilitation; stress and the body's responses to stress; aging; breathing and heartbeat; body temperature; hunger, thirst, and digestion; puberty, reproductive health, and fertility.

[0037] The compositions and the combinations according to the invention support and promote the function of the nervous system. Presumably, this effect is most prominent for supporting and promoting of the function of the central nervous system, in particular the brain.

[0038] Disorders of the nervous system

[0039] The central nervous system (CNS), comprising the brain and spinal cord, plays a pivotal role in regulating various physiological and cognitive functions in the human body. Disorders affecting the CNS encompass a broad spectrum of conditions, ranging from neurological and neurodevelopmental disorders to psychiatric disorders.

[0040] Neurological disorders involve dysfunction of the nervous system, which includes the brain, spinal cord, and peripheral nerves. Examples of neurological disorders subject to the present invention include epilepsy, headache disorders (including migraine), and neurological effects resulting from stroke, Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and tinnitus, among others. These disorders typically result from structural, biochemical, or electrical abnormalities within the nervous system. Epilepsy is a neurological disorder characterized by recurrent seizures, resulting from abnormal electrical activity in the brain. Symptoms can vary from brief staring spells to convulsions and loss of consciousness. Headache disorders encompass various types, such as tension-type headaches and migraines. These are characterized by recurrent head pain and can significantly impact daily life. Migraine itself is a neurological disorder involving recurring headaches, often accompanied by nausea, sensitivity to light, and sound. It is characterized by moderate to severe throbbing pain, usually on one side of the head. Stroke is a sudden disruption of blood flow to the brain, leading to cell damage and neurological deficits. Symptoms include weakness or paralysis on one side of the body, slurred speech, and difficulty with coordination. Alzheimer's disease is a neurodegenerative disorder leading to memory loss, cognitive decline, and changes in behavior. It is the most common cause of dementia in older adults. Parkinson's disease is a progressive neurodegenerative disorder affecting movement, characterized by tremors, stiffness, and difficulty with balance. ALS is a progressive neurodegenerative disorder affecting motor neurons, leading to muscle weakness and atrophy. Symptoms include gradual loss of voluntary muscle control, difficulty speaking, and swallowing. Multiple sclerosis is an autoimmune disorder causing inflammation and damage to the protective covering of nerve fibers. Symptoms include fatigue, numbness or weakness, difficulty walking, and problems with coordination. Tinnitus is the perception of noise or ringing in the ears when no external sound source is present. It can manifest as a buzzing, hissing, whistling, or ringing sound and may be intermittent or constant. Tinnitus can be intermittent or it can be continuous in which case it can be the cause of great distress. In some individuals, the intensity of tinnitus can be changed by shoulder, head, tongue, jaw, or eye movements. While tinnitus itself is a perceptual phenomenon related to the auditory system, its origins and mechanisms are complex and involve both the auditory and neurological systems. The perception of tinnitus involves the transmission of signals from the auditory nerves to the brain. Changes or disruptions in these neural pathways can contribute to the development or exacerbation of tinnitus. Tinnitus can also be associated with certain neurological conditions such as Meniere's disease, acoustic neuroma, or other disorders affecting the auditory and vestibular nerves.

[0041] Neurodevelopmental disorders are a group of conditions characterized by impairments in the growth and development of the central nervous system, which includes the brain and spinal cord. These disorders typically manifest early in childhood and affect various aspects of functioning, including cognition, behaviour, social interaction, and communication. Examples of neurodevelopmental disorders subject to the present invention include autism spectrum disorder, attention deficit hyperactivity disorder (ADHD), specific learning disorders, intellectual developmental disorders, and communication disorder and tic disorders. Autism Spectrum Disorder (ASD) is a complex neurodevelopmental disorder characterized by challenges in social interaction, communication, and repetitive behaviours. ASD encompasses a spectrum of conditions with varying degrees of severity. Symptoms may include difficulties in understanding and expressing emotions, challenges in forming social relationships, repetitive behaviours or interests, and differences in sensory processing. Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by persistent patterns of inattention, hyperactivity, and impulsivity that can impact daily functioning and development. Symptoms include difficulty sustaining attention, impulsive behaviour, hyperactivity, and challenges in organizing tasks. Specific Learning Disorders are disorders that affect specific academic skills, such as reading (dyslexia), writing (dysgraphia), or mathematics (dyscalculia), despite average or above-average intelligence in other areas. Symptoms include difficulty with reading, writing, or mathematical tasks that significantly impact academic performance. Intellectual Developmental Disorders are a condition characterized by limitations in intellectual functioning and adaptive behaviours, which impact everyday social and practical skills. Symptoms include intellectual functioning below average, difficulties in communication, self-care, and socialization. Communication Disorders are disorders that affect the ability to comprehend, use, and express language effectively. These include speech sound disorder (difficulty pronouncing sounds), language disorder (difficulty understanding or using words in context), and stuttering. Tic Disorders (e.g., Tourette Syndrome) are conditions characterized by repetitive, involuntary movements or vocalizations known as tics. Symptoms: include motor tics (e.g., eye blinking, head jerking) and vocal tics (e.g., throat clearing, grunting).

[0042] Psychiatric disorders, also known as mental disorders or mental illnesses, are conditions that affect a person's thoughts, emotions, behaviours, and overall mental well-being. These disorders can significantly impact an individual's ability to function in daily life. It's important to note that psychiatric disorders are diagnosed based on observed behaviours and reported experiences, and they are often classified in the Diagnostic and Statistical Manual of Mental Disorders (DSM). Examples of psychiatric disorders subject to the present invention include major depressive disorder (MDD), generalized anxiety disorder (GAD), schizophrenia, bipolar disorder, obsessive-compulsive disorder (OCD), post- traumatic stress disorder (PTSD), and eating disorders (such as anorexia nervosa and bulimia nervosa). Major Depressive Disorder is a mood disorder characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. Symptoms include depressed mood, loss of interest or pleasure, changes in sleep and appetite, fatigue, and feelings of worthlessness. Generalized Anxiety Disorder is an anxiety disorder characterized by excessive and persistent worry about various aspects of life, often without a specific cause. Symptoms include excessive worry, restlessness, fatigue, difficulty concentrating, muscle tension, and sleep disturbances. Schizophrenia is a severe and chronic mental disorder characterized by distorted thinking, hallucinations, delusions, and impaired social functioning. Symptoms include hallucinations, delusions, disorganized thinking, and reduced emotional expression. Bipolar Disorder involves mood swings between episodes of depression and periods of mania or hypomania (elevated mood and increased energy). Symptoms include depressive symptoms (similar to major depression) and manic or hypomanic symptoms (elevated mood, increased energy, impulsivity). Obsessive-Compulsive Disorder is an anxiety disorder characterized by persistent, intrusive thoughts (obsessions) and repetitive behaviors or mental acts (compulsions) performed to alleviate anxiety. Symptoms include compulsive behaviors such as handwashing, checking, or counting, and intrusive thoughts causing distress. PTSD can develop after exposure to a traumatic event, leading to symptoms such as flashbacks, nightmares, and persistent emotional distress. Symptoms include intrusive memories, avoidance of reminders, negative changes in mood and thinking, and increased arousal. Eating disorders involve unhealthy eating behaviors and distorted body image. Symptoms include restrictive eating, binge eating, purging behaviors, and excessive concern about weight and body shape.

[0043] In a particular embodiment, the present invention is concerned with a neurological disorder selected from the group consisting of headache, epilepsy, stroke, brain inflammation, such as brain infection, and neurodegenerative disease, such as Alzheimer's disease, Parkinson's disease, and multiple sclerosis. In a preferred embodiment, the present invention is concerned with a headache disorder. Within the neurological disorders, migraine is a most preferred disorder in the context of the invention. Therefore, in a particular embodiment the present invention provides compositions and combinations of substances for use in the treatment and / or prevention of a headache, preferably for the in the treatment and / or prevention of migraine.

[0044] In another particular embodiment, the present invention is concerned with a neurodevelopmental disorder selected from the group consisting of autism spectrum disorder, and a tic disorder, such as Tourette Syndrome. Therefore, in a particular embodiment the present invention provides compositions and combinations of substances for use in the treatment and / or prevention of a tic disorder, preferably for the in the treatment and / or prevention of Tourette Syndrome. In another particular embodiment the present invention provides compositions and combinations of substances for use in the treatment and / or prevention of autism spectrum disorder.

[0045] In another particular embodiment, the present invention is concerned with a psychiatric disorder selected from the group consisting of depression, anxiety, and schizophrenia. Therefore, in a particular embodiment the present invention provides compositions and combinations of substances for use in the treatment and / or prevention of depression. In another particular embodiment the present invention provides compositions and combinations of substances for use in the treatment and / or prevention of anxiety. In another particular embodiment the present invention provides compositions and combinations of substances for use in the treatment and / or prevention of schizophrenia.

[0046] In a most preferred embodiment, the present invention provides compositions and combinations of substances for use in the treatment and / or prevention of one or more disorders selected from the group consisting of migraine, autism spectrum disorder, and Tourette Syndrome.

[0047] Subjects

[0048] As used herein, the term subject, refers to any living organism which has a nervous system. Preferably, the subject has a central nervous system. More preferably the subject has a brain.

[0049] Preferably, the subject is a mammal, preferably a cat, dog, horse, donkey, sheep, pig, goat, cow, hamster, mouse, rat, rabbit, or guinea pig, but most preferably the subject is a human. Thus in all aspects of the invention as described herein the subject is preferably a human. The subject may be of any age, but preferably the subject is at least 8 years old, particularly at least 12 years old, more particularly and preferably at least 18 years old.

[0050] The subject may be immunocompetent or immunocompromised and may be symptomatic or asymptomatic. The subject may have no disorders of the nervous system, in particular no known disorders of the nervous system. However, it is preferred that the subject has, is suspected of having or is at risk of having one or more of the disorders of the nervous system, in particular the central nervous system, more in particular the brain. Preferably, the subject has one or more of the described disorders selected from the group consisting of a neurological disorder, a neurodevelopmental disorder and a psychiatric disorder. The subject can have a confirmed or a suspected disorder of the nervous system. As it is commonly known to a person skilled in the art, disorders of the nervous system can be suspected and / or confirmed by clinical methods comprising, but not limited to clinical neurological examination, medical imaging, laboratory testing (including blood analysis and analysis of cerebrospinal fluid), neuropsychological testing, and neuropsychological testing. In a particular embodiment, the subject has been diagnosed with one or more of the disorders listed in the current application prior to treatment and / or prevention of that disorder with the compositions of the invention.

[0051] Compositions

[0052] As described herein before, the current invention provides compositions, preferably comprising: vitamin B complex; vitamin E; choline; myo-inositol; coenzyme Q10 ; garlic extract; sulforaphane; carnitine; curcumin; resveratrol; and betaine.

[0053] In a further embodiment, vitamin B complex comprises : vitamin Bl, preferably thiamine mononitrate; vitamin B2, preferably riboflavin 5'-phosphate sodium; vitamin B3, preferably nicotinamide; vitamin B5, preferably calcium-d-pantothenate; vitamin B6, preferably pyridoxal 5'-phosphate; vitamin B8, preferably D-biotin; vitamin B9, preferably 5-methyltetrahydrofolate; and vitamin B12, preferably methylcobalamin.

[0054] Betain is also known in the art as trimethylglycine. Vitamin B8 is also known in the art as biotin. Vitamin B9 is also known in the art as folic acid.

[0055] The garlic extract is preferably an extract from fermented garlic, in particular an extract of Allium sativum L.. Sulforaphane is preferably comprised in a broccoli extract, in particular an extract of Brassica oleracea italiana. Curcumin is preferably comprised in a curcuma extract, in particular an extract of Curcuma longa. It is further preferred that the said curcuma extract comprises at least 95 wt. % curcuminoids. Resveratrol is preferably comprised in a Japanese knotweed extract. It is further preferred that the said Japanese knotweed extract comprises at least 95 wt. % resveratrol. In a preferred embodiment, the composition according to the current invention comprises: vitamin Bl; vitamin B2; vitamin B3; vitamin B5; vitamin B6; vitamin B8; vitamin B9; vitamin B12; vitamin E; choline; myo-inositol; coenzyme Q10 ; garlic extract; broccoli extract; carnitine; curcuma extract; Japanese knotweed extract; and betaine.

[0056] Carnitine is available as a supplement in a variety of forms, comprising, but not limited to: L- carnitine, acetyl-L-carnitine, propionyl-L-carnitine. Preferably, carnitine is acetyl-L-carnitine. In particular, acetyl-L-carnitine is considered to be the best form for brain health and function. It is further preferred that acetyl-L-carnitine is in form of acetyl-L-carnitine hydrochloride.

[0057] For the purpose of the current invention, choline is preferably in form of choline L-bitartrate. Choline L-bitartrate is choline combined with a salt of tartaric acid, which significantly promotes the absorption rate compared to pure choline.

[0058] Vitamin E is preferably a mix of tocopherols comprising alpha-tocopherol equivalents.

[0059] Thus, in a further preferred embodiment, the composition according to the current invention comprises: thiamine mononitrate; riboflavin 5'-phosphate sodium; nicotinamide; calcium-d-pantothenate; pyridoxal 5'-phosphate;

[0060] D-biotin;

[0061] 5-methyltetrahydrofolate; methylcobalamin. a mix of tocopherols comprising alpha-tocopherol equivalents; choline L-bitartrate; myo-inositol; coenzyme Q10 ; garlic extract; broccoli extract; acetyl-L-carnitine hydrochloride; curcuma extract;

[0062] Japanese knotweed extract; and betaine.

[0063] For the purpose of the present invention, the compositions would typically comprise the active ingredients in the following weight percentages with respect to the composition: vitamin Bl, in particular thiamine mononitrate, in an amount of 0.50 to 3.00 wt. %; vitamin B2, in particular riboflavin 5'-phosphate sodium, in an amount of 0.50 to 3.00 wt. %; vitamin B3, in particular nicotinamide, in an amount of 0.50 to 3.00 wt. %; vitamin B5, in particular calcium-d-pantothenate, in an amount of 2.00 to 4.00 wt. %; vitamin B6, in particular pyridoxal 5'-phosphate, in an amount of 0.10 to 0.60 wt. %; vitamin B8, in particular D-biotin, in an amount of 0.005 to 0.03 wt. %; vitamin B9, in particular 5-methyltetrahydrofolate, in an amount of 0.02 to 0.04 wt. %; vitamin B12, in particular methylcobalamin, in an amount of 0.02 to 0.04 wt. %; vitamin E, in particular a mix of tocopherols comprising alpha-tocopherol equivalents, in an amount of 0.50 to 3.00 wt. %; choline, in particular choline L-bitartrate, in an amount of 15.00 to 20.00 wt. %; myo-inositol in an amount of 0.50 to 3.00 wt. %; coenzyme Q10 in an amount of 2.00 to 4.00 wt. %; garlic extract in an amount of 12.00 to 17.00 wt. %; broccoli extract in an amount of 12.00 to 17.00 wt. %; carnitine, in particular acetyl-L-carnitine, more in particular acetyl-L-carnitine hydrochloride, in an amount of 20.00 to 40.00 wt. %; curcuma extract in an amount of 2.00 to 4.00 wt. %;

[0064] Japanese knotweed extract in an amount of 2.00 to 4.00 wt. %; and betaine in an amount of 4.00 to 8.00 wt. %.

[0065] Preferably, the described compositions are pharmaceutical compositions or nutritional supplements. The pharmaceutical compositions and nutritional supplements may further comprise one or more pharmaceutically acceptable carriers. In a particular embodiment, the current invention provides a pharmaceutical composition, comprising any one of the described compositions, and a pharmaceutically acceptable carrier. In another particular embodiment, the current invention provides a nutritional supplement, comprising any one of the described compositions.

[0066] As defined above, the term pharmaceutically acceptable carrier refers to any material which, when combined with an active ingredient, allows the ingredient to retain biological activity - in particular, any material which enhances or stabilizes the composition or can be used to facilitate preparation of the composition. Pharmaceutically acceptable carriers include solvents, dispersion media, coatings, antibacterial and antifungal agents, isotonic and absorption delaying agents, and the like that are physiologically compatible, as is known to those skilled in the art (see, for example, Remington's Pharmaceutical Sciences, 18th Ed. Mack Printing Company, 1990, pp. 1289- 1329; Remington: The Science and Practice of Pharmacy, 21st Ed. Pharmaceutical Press 2011; and subsequent versions thereof). Some non-limiting examples of materials which can serve as pharmaceutically acceptable carriers include: sugars, such as lactose, glucose and sucrose; starches, such as corn starch, potato starch and rice starch; cellulose, and its derivatives, such as sodium carboxymethyl cellulose, ethyl cellulose and cellulose acetate; powdered tragacanth; malt; gelatine; talc; excipients, such as cocoa butter and suppository waxes; oils, such as peanut oil, cottonseed oil, safflower oil, sesame oil, olive oil, corn oil and soybean oil; emulsions, such as oil / water emulsions; various types of wetting agents; glycols, such as propylene glycol; polyols, such as glycerine, sorbitol, mannitol and polyethylene glycol; esters, such as ethyl oleate and ethyl laurate; agar; buffering agents, such as magnesium hydroxide and aluminium hydroxide; alginic acid; pyrogen-free water; isotonic saline; Ringer's solution; ethyl alcohol; phosphate buffer solutions; and other non-toxic compatible substances employed in pharmaceutical formulations. The preferred pharmaceutically acceptable carrier is a starch, most preferably rice starch. Therefore, in a particular embodiment, the present invention provides a pharmaceutical composition comprising the substances of the invention in combination with a starch, preferably in combination with rice starch. Phrased otherwise, the present invention provides compositions as disclosed herein, wherein said composition is a pharmaceutical composition further comprising a starch, in particular rice starch.

[0067] The compositions of the invention may be administered enterally, or parenterally in formulations containing conventional non-toxic pharmaceutically acceptable carriers, and adjuvants as desired. In a preferred embodiment, the compositions of the invention are administered enterally. Enteral administration includes oral, sublingual, and anal or rectal administration (e.g. enema, suppository), as well as administration via a tube (e.g. gastric tube, duodenal tube). In a most preferred embodiment, the compositions according to the invention are administered orally. Thus, in a preferred embodiment, the present invention provides oral compositions comprising the substances of the invention.

[0068] Compositions comprising the substances of the invention may be in any form suitable for the intended method of administration, including, for example, a solution, a suspension or an emulsion. Liquid carriers are commonly used in the preparation of solutions, suspensions and emulsions. Liquid carriers for use of the present invention include, for example, water, saline, pharmaceutically acceptable organic solvents, pharmaceutically acceptable oils or fats and the like, as well as mixtures of two or more thereof. The liquid carrier may contain other suitable pharmaceutically acceptable additives such as solubilizers, emulsifiers, nutrients, buffers, preservatives, suspending agents, thickeners, viscosity regulators, stabilizers and the like. Suitable organic solvents include, for example, monohydric alcohols, such as ethanol, and polyhydric alcohols, such as glycols. Suitable oils include, for example, soybean oil, coconut oil, olive oil, safflower oil, cottonseed oil and the like. For parenteral administration, the carrier may also be an oily ester such as ethyl oleate, isopropyl myristate and the like. Compositions of the present invention may also be in the form of microparticles, microcapsules, liposomal encapsulates and the like, as well as combinations of two or more thereof.

[0069] Solid dosage forms may include capsules, tablets, pills, suppositories, powders and granules. In such solid dosage forms, the active compounds can be mixed with at least one inert diluent such as sucrose, lactose or starch. Such dosage forms may also, as usual, contain substances other than inert diluents, for example lubricants such as magnesium stearate. In the case of capsules, tablets, pills and suppositories, the dosage forms may also contain buffering agents. Tablets and pills can additionally be prepared with enteric coatings. The preferred solid dosage form according to the invention is selected from the group of a capsule, a tablet, or a pill. The most preferred solid dosage form is a capsule. A "capsule" refers to a dosage form enclosed in a shell or container. There are two main types, hard capsules and soft capsules. Hard capsules consist of two pieces, each containing a powdered or granulated form of the pharmaceutical composition. These pieces are typically made of gelatin or other suitable materials. Hard capsules are convenient for oral delivery of the substances of the invention in a dry or powdered form. Soft capsules are typically one-piece, hermetically sealed shells made of gelatin or other polymers. The shell encloses a liquid or semiliquid fill, which may contain the active pharmaceutical ingredient and other excipients. Soft capsules are suitable for delivering liquid or oily formulations.

[0070] Liquid dosage forms may include pharmaceutically acceptable emulsions, solutions, suspensions, syrups, elixirs, creams, foams, ointments and gels containing inert diluents commonly used in the art, such as water. Such compositions may also contain excipients such as wetting agents, emulsifying and suspending agents, cyclodextrins and sweetening, flavouring and perfuming agents.

[0071] Treatment

[0072] Effective amounts of the compounds in the compositions according to the invention generally include any amount sufficient for supporting and / or promoting of the function of the nervous system, in particular for treatment and / or prevention of one or more disorders selected a neurological disorder, a neurodevelopmental disorder and a psychiatric disorder.

[0073] This effective amount that can be combined with the pharmaceutically acceptable carriers to produce a single dosage form will vary depending on the subject treated and the route of administration. This effective amount for a given subject will depend on a variety of factors, including the form of the composition (nutritional supplement, pharmaceutical composition), the activity of the specific compound used, the animal species, age, body weight, general health, gender, diet, time of administration, route of administration, excretion rate, drug combination, general health (including, thyroid status and histamine status), and severity of any condition. The therapeutically effective amount for a particular situation is easily determined by routine experimentation and is within the skill and judgment of the skilled person.

[0074] As is well-known, a human subject to be treated according to the invention will typically have a body weight of 60 to 85 kg. The therapeutically effective dose of vitamin Bl, in particular thiamine mononitrate, will generally be from about 3 mg / day to about 50 mg / day, preferably from about 3 mg / day to about 35 mg / day. The therapeutically effective dose of vitamin B2, in particular riboflavin 5'-phosphate sodium, will generally be from about 3 mg / day to about 50 mg / day, preferably from about 3 mg / day to about 35 mg / day. The therapeutically effective dose of vitamin B3, in particular nicotinamide, will generally be from about 3 mg / day to about 50 mg / day, preferably from about 3 mg / day to about 35 mg / day. The therapeutically effective dose of vitamin B5, in particular calcium-d- pantothenate, will generally be from about 5 mg / day to about 70 mg / day, preferably from about 5 mg / day to about 55 mg / day. The therapeutically effective dose of vitamin B6, in particular pyridoxal 5'-phosphate, will generally be from about 0.5 mg / day to about 15.0 mg / day, preferably from about 0.5 mg / day to about 10.0 mg / day. The therapeutically effective dose of vitamin B8 (biotin), in particular D-biotin, will generally be from about 0.02 mg / day to about 0.50 mg / day, preferably from about 0.02 mg / day to about 0.25 mg / day. The therapeutically effective dose of vitamin B9 (folic acid), in particular 5-methyltetrahydrofolate, will generally be from about 0.05 mg / day to about 2.00 mg / day, preferably from about 0.05 mg / day to about 1.00 mg / day. The therapeutically effective dose of vitamin B12, in particular methylcobalamin, will generally be from about 0.05 mg / day to about 2.00 mg / day, preferably from about 0.05 mg / day to about 1.00 mg / day. The therapeutically effective dose of vitamin E, in particular a mix of tocopherols comprising alpha-tocopherol equivalents, will generally be from about 3 mg / day to about 50 mg / day, preferably from about 3 mg / day to about 35 mg / day. The therapeutically effective dose of choline, in particular choline L-bitartrate, will generally be from about 50 mg / day to about 500 mg / day, preferably from about 50 mg / day to about 350 mg / day. The therapeutically effective dose of myo-inositol will generally be from about 3 mg / day to about 50 mg / day, preferably from about 3 mg / day to about 35 mg / day. The therapeutically effective dose of coenzyme Q10 will generally be from about 5 mg / day to about 70 mg / day, preferably from about 5 mg / day to about 55 mg / day. The therapeutically effective dose of garlic extract will generally be from about 45 mg / day to about 400 mg / day, preferably from about 45 mg / day to about 300 mg / day. The therapeutically effective dose of broccoli extract will generally be from about 45 mg / day to about 400 mg / day, preferably from about 45 mg / day to about 300 mg / day. The therapeutically effective dose of carnitine, in particular acetyl-L-carnitine, more in particular acetyl-L-carnitine hydrochloride, will generally be from about 50 mg / day to about 1000 mg / day, preferably from about 50 mg / day to about 600 mg / day. The therapeutically effective dose of curcuma extract will generally be from about 5 mg / day to about 70 mg / day, preferably from about 5 mg / day to about 55 mg / day. The therapeutically effective dose of Japanese knotweed extract will generally be from about 5 mg / day to about 70 mg / day, preferably from about 5 mg / day to about 55 mg / day. The therapeutically effective dose of vitamin B5, in particular calcium-d-pantothenate, will generally be from about 10 mg / day to about 150 mg / day, preferably from about 10 mg / day to about 120 mg / day.

[0075] In a preferred embodiment, the compositions according to the present invention are administered in a daily dose of: vitamin Bl in an amount of 20 to 35 mg; vitamin B2 in an amount of 20 to 40 mg; vitamin B3 in an amount of 15 to 30 mg; vitamin B5 in an amount of 25 to 75 mg; vitamin B6 in an amount of 1 to 8 mg; vitamin B8 in an amount of 0.05 to 0.3 mg; vitamin B9 in an amount of 0.2 to 0.6 mg; vitamin B12 in an amount of 0.2 to 0.6 mg; vitamin E in an amount of 15 to 50 mg; choline in an amount of 80 to 180 mg; myo-inositol in an amount of 15 to 40 mg; coenzyme Q10 in an amount of 30 to 200 mg; garlic extract in an amount of 100 to 300 mg; broccoli extract in an amount of 100 to 300 mg; carnitine in an amount of 250 to 750 mg; curcuma extract in an amount of 25 to 100 mg;

[0076] Japanese knotweed extract in an amount of 20 to 100 mg; and betaine in an amount of 25 to 150 mg.

[0077] The compositions according to the invention and the other active substances can be administered at the recommended maximum dose or at a lower dose. Dosage levels of the active ingredients in the compositions of the invention can be varied to obtain a desired effect depending on the route of administration, the severity of the condition and the response of the subject.

[0078] For each of the recited embodiments, the dosage is typically administered from one to four times a day, although more frequent dosing intervals are possible. In a preferred embodiment, particularly when the subject is 12 years or more, preferably 16 years or more, more preferably 18 years of more, the dosage is administered four times a day. As is evident from the disclosures herein, in such embodiment, the daily dosages disclosed herein are divided by four to determine the (unitary) dosage.

[0079] Therefore, in a preferred embodiment, the composition of the invention is provided as a unitary dose comprising: vitamin Bl in an amount of 5 to 35 mg; vitamin B2 in an amount of 4 to 40 mg; vitamin B3 in an amount of 3.75 to 30 mg; vitamin B5 in an amount of 6.25 to 75 mg; vitamin B6 in an amount of 0.25 to 8 mg; vitamin B8 in an amount of 0.012 to 0.3 mg; vitamin B9 in an amount of 0.05 to 0.6 mg; vitamin B12 in an amount of 0.05 to 0.6 mg; vitamin E in an amount of 3.75 to 50 mg; choline in an amount of 20 to 180 mg; myo-inositol in an amount of 3.75 to 40 mg; coenzyme Q10 in an amount of 7.5 to 200 mg; garlic extract in an amount of 25 to 300 mg; broccoli extract in an amount of 25 to 300 mg; carnitine in an amount of 62.5 to 750 mg; curcuma extract in an amount of 6.25 to 100 mg;

[0080] Japanese knotweed extract in an amount of 4 to 100 mg; and betaine in an amount of 6.25 to 150 mg.

[0081] In a particular embodiment, the composition of the invention is provided as a unitary dose comprising: vitamin Bl in an amount of 5 to 8.75 mg; vitamin B2 in an amount of 4 to 10 mg; vitamin B3 in an amount of 3.75 to 7.5 mg; vitamin B5 in an amount of 6.25 to 18.75 mg; vitamin B6 in an amount of 0.25 to 2 mg; vitamin B8 in an amount of 0.012 to 0.075 mg; vitamin B9 in an amount of 0.05 to 0.15 mg; vitamin B12 in an amount of 0.05 to 0.15 mg; vitamin E in an amount of 3.75 to 12.5 mg; choline in an amount of 20 to 45 mg; myo-inositol in an amount of 3.75 to 10 mg; coenzyme Q10 in an amount of 7.5 to 50 mg; garlic extract in an amount of 25 to 75 mg; broccoli extract in an amount of 25 to 75 mg; carnitine in an amount of 62.5 to 750 mg; curcuma extract in an amount of 6.25 to 25 mg;

[0082] Japanese knotweed extract in an amount of 4 to 25 mg; and betaine in an amount of 6.25 to 37.5 mg.

[0083] In a further particular embodiment, the composition of the invention is provided in a capsule for oral administration comprising: vitamin Bl in an amount of about 7.4 mg; vitamin B2 in an amount of about 7.5 mg; vitamin B3 in an amount of about 5 mg; vitamin B5 in an amount of about 12.5 mg; vitamin B6 in an amount of about 1.5 mg; vitamin B8 in an amount of about 0.05 mg; vitamin B9 in an amount of about 0.125 mg; vitamin B12 in an amount of about 0.125 mg; vitamin E in an amount of about 9 mg; choline in an amount of about 30 mg; myo-inositol in an amount of about 6.25 mg; coenzyme Q10 in an amount of about 12.5 mg; garlic extract in an amount of about 62.5 mg; broccoli extract in an amount of about 62.5 mg; carnitine in an amount of about 125 mg; curcuma extract in an amount of about 13.16 mg;

[0084] Japanese knotweed extract in an amount of about 12.5 mg; and betaine in an amount of about 25 mg.

[0085] The dosage may be administered every day, every 2 days, every 3 days, every 4 days, every 5 days, every 6 days, and / or every 7 days (once a week). In one embodiment, the compositions may be administered daily for at least 7-10 days, particularly for at least 30 days. In another embodiment, the unitary dosage may be administered four times a day for at least 7-10 days, particularly for at least 30 days. If the patient requires treatment for a chronic disease or condition, the dosage may be administered for as long as signs and / or symptoms persist. The patient may require "maintenance treatment" where the patient is receiving dosages every day for months, years, or the remainder of their lives. In addition, the composition of this invention may be to effect prophylaxis of recurring symptoms. For example, the dosage may be administered once or twice a day to prevent the onset of symptoms in patients at risk, especially for asymptomatic patients.

[0086] Combinations

[0087] The compositions of the present invention may be administered alone or in combination with one or more other agents for the use described. The active substances according to the invention can, for example, be combined with prebiotics, antibiotics, probiotics, vitamins and nutrients.

[0088] Preferably, the active substances according to the invention are combined with one or more other substances, which support and / or promote the function of the nervous system. These one or more other substances may be selected from the group of substances selected from the group of Siberian ginseng root extract, rhodiola extract, maca extract, ashwagandha extract, Schisandra berry extract, vitamin A, vitamin C, vitamin D3, Vitamin K2, zinc, selenium, manganese, molybdenum, boron, chromium, iodine, beta-carotene, lutein, zeaxanthin, lycopene, citrus flavonoids, alpha-lipoic acid, flaxseed oil, algae oil, chia seed oil, echium seed oil, ahiflower oil, blackcurrant seed oil, olive tree extract, grape seed extract, and astaxanthin.

[0089] In one particular further embodiment, the present invention provides a combination of the composition as described herein with one or more substances selected from the group consisting of Siberian ginseng root extract, rhodiola extract, maca extract, ashwagandha extract, and Schisandra berry extract. In another further embodiment, the present invention provides a combination of the composition as described herein with one or more substances selected from the group consisting of vitamin A, vitamin C, vitamin D3, Vitamin K2, zinc, selenium, manganese, molybdenum, boron, chromium, iodine, beta-carotene, lutein, zeaxanthin, lycopene, citrus flavonoids, and alpha-lipoic acid. In yet another further embodiment, the present invention provides a combination of the composition as described herein with one or more substances selected from the group consisting of flaxseed oil, algae oil, chia seed oil, echium seed oil, ahiflower oil, blackcurrant seed oil, olive tree extract, grape seed extract, and astaxanthin. It is of particular interest to combine the composition of the invention with one or more substances selected from the group consisting of vitamin A, vitamin C, vitamin D3, Vitamin K2, zinc, selenium, manganese, molybdenum, boron, chromium, iodine, beta-carotene, lutein, zeaxanthin, lycopene, citrus flavonoids, and alpha-lipoic acid; particularly with at least 6, 7 or 8 of the substances; preferably with all of vitamin A, vitamin C, vitamin D3, Vitamin K2, zinc, selenium, manganese, molybdenum, boron, chromium, iodine, beta-carotene, lutein, zeaxanthin, lycopene, citrus flavonoids, and alpha-lipoic acid.

[0090] The combinations according to the invention may be administered as separate compositions or as a single dosage form containing all compounds. When administered as a combination, the therapeutic compounds can be formulated as separate compositions given simultaneously or at different times, or the therapeutic compounds can be given as a single composition.

[0091] EXAMPLES

[0092] Example 1: Treatment of migraine

[0093] To assess the effectiveness of the compositions of the invention in treating migraine, a patient diagnosed with recurring migraine was administered four capsules per day, each capsule comprising: vitamin Bl in an amount of 7.4 mg; vitamin B2 in an amount of 7.5 mg; vitamin B3 in an amount of 5 mg; vitamin B5 in an amount of 12.5 mg; vitamin B6 in an amount of 1.5 mg; vitamin B8 in an amount of 0.05 mg; vitamin B9 in an amount of 0.125 mg; vitamin B12 in an amount of 0.125 mg; vitamin E in an amount of 9 mg; choline in an amount of 30 mg; myo-inositol in an amount of 6.25 mg; coenzyme Q10 in an amount of 12.5 mg; garlic extract in an amount of 62.5 mg; broccoli extract in an amount of 62.5 mg; carnitine in an amount of 125 mg; curcuma extract in an amount of 13.16 mg;

[0094] Japanese knotweed extract in an amount of 12.5 mg; and betaine in an amount of 25 mg.

[0095] Treatment was performed during three months, migraine emergence was assessed after one month of treatment for two months. Prior to treatment, the patient experienced regular migraines for more than 5 years. In the last year before treatment, migraines occurred daily. The patient previously underwent various migraine treatment regimes, which were only able to reduce migraine intensity and duration to a limited extend. After one month of treatment with the composition of the invention, the patient experienced migraine occurrence about one time per month. Given the frequent, daily migraine occurrences before treatment, this example demonstrates a surprising effectiveness of the composition of the invention. Example 2: Treatment of migraine

[0096] To assess the effectiveness of the compositions of the invention in treating migraine, another patient diagnosed with recurring migraine was treated according to the treatment regime of example 1.

[0097] Treatment was performed during two months, migraine emergence was assessed during the treatment period. In the year prior to treatment, the patient experienced nearly daily headaches and migraines occurring about 20 times per month. After 5 days of treatment with the composition of the invention, the patient experienced no migraine occurrences for the further duration of the treatment. Given the frequent migraine occurrences before treatment, this example confirms the surprising effectiveness of the composition of the invention also observed in example 1.

[0098] Example 3: Treatment of Tourette Syndrome

[0099] To assess the effectiveness of the compositions of the invention in treating Tourette Syndrome and Autism Spectrum Disorder, a patient diagnosed with Autism Spectrum Disorder and Tourette Syndrome was treated according to the treatment regime of example 1.

[0100] Treatment was performed during 4 weeks, after which the emergence of tics and social interactions was assessed by interview. The male patient was diagnosed with Autism Spectrum Disorder for 5 years and developed Tourette Syndrome in the year before treatment. Prior to treatment, the patient had lived a generally isolated live with limited social interactions and experienced tics multiple times per hour, particularly uncontrolled verbal exclamations and word repetitions. After 4 weeks of treatment with the composition of the invention, verbal tics still occurred about 1 to 2 times per day. The significant and unexpectedly strong reduction in tics occurrence demonstrates the surprising effectiveness of the composition of the invention. People close to the patient noted improved skills and a higher frequency of initiating social interactions.

Claims

CLAIMS1. A composition, comprising: vitamin Bl; vitamin B2; vitamin B3; vitamin B5; vitamin B6; vitamin B8; vitamin B9; vitamin B12; vitamin E; choline; myo-inositol; coenzyme Q10 ; garlic extract; sulforaphane; carnitine; curcumin; resveratrol; and betaine.

2. The composition according to claim 1, wherein: sulforaphane is comprised in a broccoli extract; curcumin is comprised in a curcuma extract; and resveratrol is comprised in a Japanese knotweed extract.

3. The composition according to claim 1 or 2, comprising: vitamin Bl in an amount of 0.50 to 3.00 wt. %; vitamin B2 in an amount of 0.50 to 3.00 wt. %; vitamin B3 in an amount of 0.50 to 3.00 wt. %; vitamin B5 in an amount of 2.00 to 4.00 wt. %; vitamin B6 in an amount of 0.10 to 0.60 wt. %; vitamin B8 (biotin) in an amount of 0.005 to 0.03 wt. %; vitamin B9 (folic acid) in an amount of 0.02 to 0.04 wt. %; vitamin B12 in an amount of 0.02 to 0.04 wt. %; vitamin E in an amount of 0.50 to 3.00 wt. %; choline in an amount of 15.00 to 20.00 wt. %; myo-inositol in an amount of 0.50 to 3.00 wt. %; coenzyme Q10 in an amount of 2.00 to 4.00 wt. %; garlic extract in an amount of 12.00 to 17.00 wt. %; broccoli extract in an amount of 12.00 to 17.00 wt. %; carnitine in an amount of 20.00 to 40.00 wt. %; curcuma extract in an amount of 2.00 to 4.00 wt. %;Japanese knotweed extract in an amount of 2.00 to 4.00 wt. %; and betaine in an amount of 4.00 to 8.00 wt. %; wherein the wt. % is expressed as a wt. % over the total amount of substances a to r.

4. The composition according to any one of the previous claims, wherein carnitine is acetyl-L- carnitine.

5. A composition according to any one of claims 1 to 4, which is a pharmaceutical composition, further comprising a pharmaceutically acceptable carrier.

6. A composition according to any one of claims 1 to 4, which is a nutritional supplement.

7. A combination of the composition according to any one of claims 1 to 6 with one or more substances selected from the group consisting of Siberian ginseng root extract, rhodiola extract, maca extract, ashwagandha extract, Schisandra berry extract, vitamin A, vitamin C, vitamin D3, Vitamin K2, zinc, selenium, manganese, molybdenum, boron, chromium, iodine, beta-carotene, lutein, zeaxanthin, lycopene, citrus flavonoids, alpha-lipoic acid, flaxseed oil, algae oil, chia seed oil, echium seed oil, ahiflower oil, blackcurrant seed oil, olive tree extract, grape seed extract, and astaxanthin.

8. The composition according to any one of claims 1 to 6, or the combination according to claim 7 for use as a medicine.

9. The composition according to any one of claims 1 to 6, or the combination according to claim 7 for use in supporting and / or promoting the function of the nervous system.

10. The composition for the use according to claim 9, wherein supporting and promoting of the function of the nervous system comprises treatment and / or prevention of one or more disorders selected from the group consisting of a neurological disorder, a neurodevelopmental disorder and a psychiatric disorder.

11. The composition for the use according to claim 10, wherein the neurological disorder is selected from the group consisting of headache, epilepsy, stroke, brain inflammation, such as brain infection, and neurodegenerative disease, such as Alzheimer's disease, Parkinson's disease, and multiple sclerosis; wherein the neurodevelopmental disorder is selected from the group consisting of autism spectrum disorder, and tic disorder, such as Tourette Syndrome; wherein the psychiatric disorder is selected from the group consisting of depression, anxiety, and schizophrenia.

12. The composition or the combination for the use according to any one of claims 8 to 11, wherein the use comprises administration of the composition or the combination to a human subject; preferably by oral administration.

13. The composition or the combination for the use according to any one of claims 8 to 12, wherein the use comprises administration of the composition in a dose of 300 mg to 2000 mg per day.

14. The composition according to any one of claims 1 to 4, for use in the treatment and / or prevention of one or more disorders selected from the group consisting of migraine, autism spectrum disorder, and Tourette Syndrome in a human subject, wherein the treatment / and or prevention comprises oral administration of the composition, and wherein administration of the composition results in a daily dose of:vitamin Bl in an amount of 20 to 35 mg; vitamin B2 in an amount of 20 to 40 mg; vitamin B3 in an amount of 15 to 30 mg; vitamin B5 in an amount of 25 to 75 mg; vitamin B6 in an amount of 1 to 8 mg; vitamin B8 in an amount of 0.05 to 0.3 mg; vitamin B9 in an amount of 0.2 to 0.6 mg; vitamin B12 in an amount of 0.2 to 0.6 mg; vitamin E in an amount of 15 to 50 mg; choline in an amount of 80 to 180 mg; myo-inositol in an amount of 15 to 40 mg; coenzyme Q10 in an amount of 30 to 200 mg; garlic extract in an amount of 100 to 300 mg; broccoli extract in an amount of 100 to 300 mg; carnitine in an amount of 250 to 750 mg; curcuma extract in an amount of 25 to 100 mg;Japanese knotweed extract in an amount of 20 to 100 mg; and betaine in an amount of 25 to 150 mg.

15. A capsule comprising the composition according to any one of claims 1 to 6 or the composition for the use according to any one of claims 8 to 14.