Composition containing choline bitartrate, bacopa, cordyceps, and hericium for preventing and treating neurodegenerative diseases and cognitive disorders such as parkinson's and alzheimer's

Abstract

A composition for preventing and treating neurodegenerative diseases and cognitive disorders is provided, comprising a mixture of active ingredients, including choline bitartrate, Cordyceps, Hericium, and Bacopa.

Description

[0001] COMPOSITION CONTAINING CHOLINE BITARTRATE, BACOPA, CORDYCEPS, AND HERICIUM FOR PREVENTING AND TREATING NEURODEGENERATIVE DISEASES AND COGNITIVE DISORDERS SUCH AS PARKINSON'S AND ALZHEIMER'S

[0002] The present invention relates to a composition for use in the treatment and prevention of neurodegenerative diseases and cognitive disorders.

[0003] It originates in the field of pharmaceuticals, nutraceuticals, and dietary supplements and concerns a preparation for administration, preferably oral, suitable for preventing or treating cognitive disorders, cerebral involutional processes, and degenerative processes of nerve cells.

[0004] Cognitive disorders typically affect the adult population aged over 50-60 years and in particular, it has emerged that approximately 5% of the population over 65 years old and about 30% of the population over 85 years old suffer from a cognitive disorder.

[0005] The main cognitive disorders can be classified into three types of diseases: reversible, vascular, and degenerative diseases.

[0006] In the first type, the onset of the disease is traumatic or results from an external agent, such as an infection, and tends to regress once the triggering cause is corrected.

[0007] Conversely, the other two types, more representative of cognitive disorders, have a matrix of progressive degeneration. In detail, since these are chronic diseases, it is not possible to restore the initial physiological condition, but it is only possible to slow the progression of the disease and control its symptoms. Typical examples of vascular degenerative diseases include cerebrovascular insufficiency, stroke, transient ischemic attack, and cerebral haemorrhages. Generally, when the first symptoms of a form of cerebral decline manifest (such as, for example, loss of balance and movement difficulties and / or speaking difficulties), indications are given to initiate an appropriate therapeutic treatment aimed at slowing the progression of the disease and preventing acute events.

[0008] The type of therapeutic treatment is selected based on the severity of the symptoms and the individual’s age.

[0009] The initial forms of cognitive decline are generally treated by supplementing the diet with specific nutritional products, herbal products with antioxidant or cerebrovascular action. The nutraceutical products currently used to prevent or treat mild forms of cognitive decline generally contain, for example, vitamins or selenium, resveratrol, omega-3, and omega-6 fatty acids.

[0010] Pharmacological therapy, on the other hand, is reserved for treating moderate-to- severe forms in which the symptoms related to cognitive decline begin to impact the quality of life and daily activities of the individual. The drugs currently most used for treating moderate-to-severe cognitive decline forms, such as senile dementia and Alzheimer’s disease, include acetylcholinesterase inhibitors, such as, for example, donepezil, rivastigmine, and galantamine. Other drugs, such as memantine, are reserved for treating the more severe forms of neurodegenerative diseases and Alzheimer’s disease.

[0011] The known technique described includes some important drawbacks.

[0012] In particular, it has been found that administering these drugs is accompanied, in most cases, by the appearance of side effects.

[0013] Furthermore, the nutraceutical products currently on the market and suitable for treating mild or moderate forms of cognitive disorders provide an inadequate or entirely unsatisfactory therapeutic response. Currently, therefore, there is a gap in the market for products for treating involutional diseases and mild cognitive disorders, as there are hardly any products available that exert a nootropic action substantially free of side effects, even in the case of prolonged intake for chronic treatments.

[0014] Additionally, it is emphasized that these drawbacks are particularly accentuated in patients in an advanced or terminal stage of the disease.

[0015] Indeed, in such cases, the physician tends to increase the dosage continually. However, this increase does not result in a corresponding enhancement in the effectiveness of the treatment but rather causes increasingly severe side effects that frequently lead to intolerance to the treatment, ultimately necessitating its discontinuation.

[0016] In this context, the technical task underlying the present invention is to devise a composition for preventing and treating neurodegenerative diseases and cognitive disorders capable of substantially overcoming at least part of the aforementioned drawbacks.

[0017] Within said technical task, an important object of the invention is to obtain a composition for improving the clinical condition and / or symptoms deriving from neurodegenerative diseases and cognitive disorders. In particular, the aim is to create a composition for preventing and treating neurodegenerative diseases and cognitive disorders, especially at an advanced stage, without requiring prolonged therapies and / or continuous dosage escalation.

[0018] Another important object of the invention is to provide a composition for preventing or treating neurodegenerative disorders and cognitive disorders, the administration of which, especially if chronic, is not accompanied by severe side effects and allows for long-term treatment of neurodegenerative disorders. A further objective is a method for preventing or treating neurodegenerative or cognitive disorders in a mammal, particularly a human being.

[0019] The technical task and specified objectives are achieved by a composition for preventing and treating neurodegenerative diseases and cognitive disorders as claimed in the attached claim 1. Examples of the referred embodiments are described in the dependent claims.

[0020] In this document, measurements, values, shapes, and geometric references (such as perpendicularity and parallelism), when associated with words like "about" or similar terms such as "approximately" or "substantially", are to be understood as allowing for measurement errors or inaccuracies due to production and / or manufacturing errors and, above all, to allow for a slight deviation from the value, measure, shape, or geometric reference with which it is associated. For example, such terms, if associated with a value, preferably indicate a deviation of no more than 10% of the value itself.

[0021] The measurements and data reported in this text are to be considered, unless otherwise indicated, as carried out under Standard International Atmosphere ICAO (ISO 2533:1975).

[0022] The present invention provides a composition for preventing and / or treating neurodegenerative and / or cognitive disorders in a mammal, preferably in a human patient. The composition of the invention can, therefore, be applied to the prevention or treatment of cognitive disorders, regardless of their origin, and / or as an adjuvant against the symptoms associated with such disorders.

[0023] According to some embodiments, the composition is a pharmaceutical composition, a nutraceutical product, or a dietary supplement that, for example, can be introduced into the diet of an individual affected by a neurodegenerative and / or cognitive disorder.

[0024] The composition comprises a mixture of active ingredients and, as appropriate, one or more excipients.

[0025] The mixture of active ingredients may comprise at least one cholinergic agent, i.e., an active ingredient belonging to the family of cholinergics, such as, for example, choline alfoscerate, choline chloride, citicoline, and choline bitartrate.

[0026] Preferably, said at least one cholinergic agent comprises (and is specifically identifiable as) a single cholinergic agent, and more preferably, only choline bitartrate.

[0027] The content of said at least one cholinergic agent, and specifically choline, appropriately in the form of choline bitartrate, may be substantially between 2000 mg and 500 mg, specifically between 1500 mg and 750 mg, and, for example, substantially 1000 mg.

[0028] Appropriately, the content of said at least one cholinergic agent, and specifically choline bitartrate, may be at least approximately 10%, and specifically approximately between 55% and 15%, more specifically between 35% and 15%, of the total weight of the active ingredients mixture. For example, it may be approximately 19% of the active ingredients mixture.

[0029] The mixture of active ingredients may comprise Bacopa, specifically extracts of Bacopa Monnieri (hereinafter simply referred to as Bacopa). These extracts may be obtained from the leaves and stem of Bacopa.

[0030] The content of Bacopa extracts may be substantially less than 100%, specifically 50%, and, for example, substantially between 30% and 20% of the content of said at least one cholinergic agent, specifically choline bitartrate.

[0031] The content of Bacopa extracts may be substantially between 1000 mg and 100 mg, specifically between 500 mg and 100 mg, more specifically between 300 mg and 200 mg, and, for example, substantially 250 mg.

[0032] Appropriately, the content of Bacopa extracts is substantially less than 20%, and specifically substantially between 15% and 3%, particularly between 14% and 4.5%, more particularly between 7% and 4.5%, of the total weight of the mixture. For example, it may be approximately 4.7% of the weight of the active ingredients mixture.

[0033] The mixture of active ingredients may comprise Hericium erinaceus (hereinafter simply referred to as Hericium).

[0034] The content of Hericium may be substantially less than 100%, specifically 75%, and, for example, substantially between 60% and 50% of the total weight of the mixture. The content of Hericium may be substantially between 4000 mg and 500 mg, and specifically between 3500 mg and 2000 mg.

[0035] In particular, Hericium may be present in the form of Hericium erinaceus extracts. These extracts may be obtained from the sporophore, i.e., the part that grows above ground or on tree trunks, commonly referred to as "mushroom."

[0036] The content of Hericium extracts may be substantially less than 100%, specifically 50%, and, for example, substantially between 35% and 25% of the content of said at least one cholinergic agent and specifically choline bitartrate. The content of Hericium extracts may be substantially greater than the content of Bacopa extracts. The content of Hericium extracts may be substantially less than 2000 mg and specifically less than 1000 mg. Preferably, it is between 500 mg and 100 mg, and more preferably between 350 mg and 250 mg, for example, approximately 300 mg. Appropriately, the content of Hericium extracts is substantially less than 30%, and in particular, 20% of the total weight of the mixture. For example, the content of these extracts may be substantially between 17% and 5% of the total weight of the active ingredients mixture. For instance, it may be approximately 5.7% of the weight of the active ingredients mixture.

[0037] In some cases, additionally or alternatively, Hericium may be present in whole form, hereinafter simply referred to as whole Hericium, for example, in appropriately dried powder form. Preferably, Hericium is present both in whole form and as extracts.

[0038] It is noted that "whole / whole form" indicates a form obtained, for example, through shredding / grinding / powdering as known to an expert in the field. The whole form is thus distinct from extracts, which identify a concentrated form of active ingredients obtained using known extraction methods, as described below.

[0039] The content of whole Hericium may be substantially between 1000 mg and 500 mg, and more preferably between 800 mg and 600 mg, and, for example, approximately 700 mg.

[0040] Appropriately, the content of whole Hericium is substantially less than 30%, and in particular between 15% and 10% of the total weight of the active ingredients mixture. For example, it is approximately 13.3% of the weight of the active ingredients mixture.

[0041] The content of whole Hericium may be substantially at least equal to and, specifically, substantially at least double the content of Hericium extracts. Preferably, the mixture comprises Hericium extracts and whole Hericium.

[0042] The mixture of active ingredients may comprise Cordyceps sinensis (hereinafter simply referred to as Cordyceps).

[0043] In particular, Cordyceps may be present in the form of Cordyceps extracts. These extracts may be obtained from the mycelium of Cordyceps.

[0044] The content of Cordyceps extracts may be substantially less than 100% of the content of said at least one cholinergic agent, specifically choline bitartrate.

[0045] In one embodiment, the content of Cordyceps extracts may be substantially between 100% and 90% of the content of said at least one cholinergic agent and specifically choline bitartrate. The content of Cordyceps extracts may be substantially greater than the content of Bacopa extracts and Hericium extracts.

[0046] In another embodiment, the content of Cordyceps extracts may be substantially between 100% and 90% of the content of said at least one cholinergic agent, specifically choline bitartrate. The content of Cordyceps extracts may be substantially greater than the content of Bacopa extracts and, for example, equal to that of Hericium extracts.

[0047] The content of Cordyceps extracts may be substantially less than 1000 mg and, more precisely, substantially between 1000 mg and 200 mg. For example, the content of Cordyceps extracts may be approximately 300 mg or 900 mg.

[0048] Appropriately, the content of Cordyceps extracts is substantially less than 30%, and in particular 20%, and appropriately between 20% and 5%. It may be substantially between 17% and 9% of the total weight of the active ingredients mixture. For example, the content of Cordyceps extracts is approximately 17.1 % of the weight of the active ingredients mixture.

[0049] In some cases, additionally or alternatively, Cordyceps may be present in whole form, hereinafter simply referred to as whole Cordyceps, for example, in appropriately dried powder form. Preferably, Cordyceps is present both in whole form and as extracts.

[0050] The content of whole Cordyceps may be substantially between 3000 mg and 500 mg, and more preferably between 2500 mg and 1000 mg, and, for example, approximately 2100 mg. Appropriately, the content of whole Cordyceps is substantially at least 15%, in particular 30%, and more particularly between 30% and 50%, and specifically between 35% and 45% of the total weight of the active ingredients mixture. For example, it is approximately 40% of the weight of the active ingredients mixture. The content of whole Cordyceps may be substantially at least equal to and, specifically, substantially at least double the content of Cordyceps extracts.

[0051] The mixture of active ingredients may comprise palmitoylethanolamide (PEA).

[0052] The content of palmitoylethanolamide may be substantially less than 100%, specifically 40%, and, for example, substantially between 25% and 15% of the content of said at least one cholinergic agent and specifically choline bitartrate. The content of palmitoylethanolamide may be substantially less than the content of Bacopa extracts.

[0053] The content of palmitoylethanolamide may be substantially less than 500 mg, specifically less than 300 mg, and more specifically substantially between 250 mg and 150 mg. For example, it may be approximately 200 mg.

[0054] Appropriately, the content of palmitoylethanolamide is substantially less than 15% and, specifically, 10% of the total weight of the active ingredients mixture. It may be substantially between 10% and 5%, particularly between 7% and 5%, of the total weight of the active ingredients mixture.

[0055] The mixture of active ingredients may comprise creatine. Preferably, this mixture includes creatine identifiable as a creatine-based compound and, specifically, creatine and pyruvate (commonly referred to as creatine pyruvate). More preferably, the mixture comprises a creatine-based compound identifiable as L-creatine pyruvate. Most preferably, it comprises L-creatine pyruvate and does not include R- creatine pyruvate. The content of creatine may be substantially less than 100%, specifically 40%, and, for example, substantially between 25% and 15% of the content of said at least one cholinergic agent and specifically choline bitartrate. The content of creatine may be substantially less than the content of Bacopa extracts and, for example, equal to that of palmitoylethanolamide.

[0056] The content of creatine may be substantially less than 500 mg and specifically less than 300 mg, and more specifically substantially between 250 mg and 150 mg. For example, it may be approximately 200 mg.

[0057] Appropriately, the content of creatine is substantially less than 15% and, specifically, 10% of the total weight of the active ingredients mixture. It may be substantially between 10% and 5%, particularly between 7% and 5%, of the total weight of the active ingredients mixture.

[0058] The mixture of active ingredients may comprise alpha-lipoic acid. Preferably, this mixture includes alpha-lipoic acid identifiable as R-alpha-lipoic acid and, in particular, R(+)-alpha-lipoic acid.

[0059] The content of alpha-lipoic acid may be substantially less than 100% and, specifically 40%, and, for example, substantially between 25% and 15% of the content of said at least one cholinergic agent and specifically choline bitartrate. The content of alpha-lipoic acid may be substantially less than the content of Bacopa extracts and, for example, equal to that of palmitoylethanolamide.

[0060] The content of alpha-lipoic acid may be substantially less than 500 mg and specifically less than 300 mg, and more specifically substantially between 250 mg and 150 mg. For example, it may be approximately 200 mg.

[0061] Appropriately, the content of alpha-lipoic acid is substantially less than 15% and, specifically, 10% of the total weight of the active ingredients mixture. It may be substantially between 10% and 5%, particularly between 7% and 5%, of the total weight of the active ingredients mixture.

[0062] The mixture of active ingredients may comprise one or more B vitamins, i.e., vitamins belonging to the B group.

[0063] The content of B vitamins may be substantially less than 20 mg, specifically less than 10 mg, and more specifically substantially between 7 mg and 4 mg. For example, it may be approximately 5 mg.

[0064] Appropriately, the content of B vitamins is substantially less than 10% and, specifically, 7.5% of the total weight of the active ingredients mixture. It may be substantially between 7% and 4%, and, for example, between 5.5% and 4.5% of the total weight of the active ingredients mixture.

[0065] These one or more vitamins may include vitamin B1 .

[0066] The content of vitamin B1 may be substantially less than 1 mg and, for example, approximately 0.55 mg.

[0067] Appropriately, the content of vitamin B1 is substantially less than 0.5% and, specifically, substantially between 0.03% and 0.01 % of the total weight of the active ingredients mixture.

[0068] The one or more vitamins may include vitamin B2.

[0069] The content of vitamin B2 may be substantially less than 1 mg and, for example, approximately 0.7 mg.

[0070] Appropriately, the content of vitamin B2 is substantially less than 0.5% and, specifically, substantially between 0.03% and 0.01 % of the total weight of the active ingredients mixture.

[0071] The one or more vitamins may include vitamin B5.

[0072] The content of vitamin B5 may be substantially less than 5 mg and, for example, substantially between 5 mg and 1 mg, and specifically equal to 3 mg.

[0073] Appropriately, the content of vitamin B5 is substantially less than 0.5% and, specifically, substantially between 0.2% and 0.05% of the total weight of the active ingredients mixture.

[0074] The one or more vitamins may include vitamin B6.

[0075] The content of vitamin B6 may be substantially less than 1 mg and, for example, approximately 0.7 mg.

[0076] Appropriately, the content of vitamin B6 is substantially less than 0.5% and, specifically, substantially between 0.03% and 0.01 % of the total weight of the active ingredients mixture.

[0077] The one or more vitamins may include vitamin B9.

[0078] The content of vitamin B9 may be substantially less than 0.5 mg and, for example, approximately 0.1 mg.

[0079] Appropriately, the content of vitamin B9 is substantially less than 0.5% and, specifically, substantially equal to 0.01 % of the total weight of the active ingredients mixture.

[0080] The one or more vitamins may include vitamin B12.

[0081] The content of vitamin B12 may be substantially less than 0.01 mg and, for example, approximately 0.005 mg.

[0082] Appropriately, the content of vitamin B12 is substantially less than 0.1 % and, specifically, 0.0001 % of the total weight of the active ingredients mixture.

[0083] It is specified that preferably, the active ingredients mixture includes exclusively one or more, and specifically the totality of the following B vitamins: B1 , B2, B5, B6, B9, and B12.

[0084] Appropriately, the active ingredients mixture comprises B vitamins excluding B3. In a first non-limiting embodiment of the composition, the mixture may have a weight of 1855 mg. It may comprise and specifically consist of: 1000 mg of said at least one cholinergic agent (preferably choline bitartrate); 250 mg of Bacopa extracts; 300 mg of Hericium extracts; 300 mg of Cordyceps extracts and approximately 5 mg of B vitamins (appropriately including 0.55 mg of B1 , 0.7 mg of B2, 3 mg of B5, 0.7 mg of B6, 0.1 mg of B9, and 0.00125 mg of B12).

[0085] In a second non-limiting embodiment of the composition, the mixture may have a weight of 5255 mg. It may comprise and specifically consist of: 1000 mg of said at least one cholinergic agent (preferably choline bitartrate); 250 mg of Bacopa extracts; 300 mg of Hericium extracts; 700 mg of whole Hericium; 900 mg of Cordyceps extracts; 2100 mg of whole Cordyceps and approximately 5 mg of B vitamins (appropriately including 0.55 mg of B1 , 0.7 mg of B2, 3 mg of B5, 0.7 mg of B6, 0.1 mg of B9, and 0.00125 mg of B12).

[0086] In a further non-limiting embodiment of the composition, the mixture may have a weight of 3155 mg. It may comprise and specifically consist of: 1000 mg of said at least one cholinergic agent (preferably choline bitartrate); 250 mg of Bacopa extracts; 300 mg of Hericium extracts; 700 mg of whole Hericium; 900 mg of Cordyceps extracts; approximately 5 mg of B vitamins (appropriately including 0.55 mg of B1 , 0.7 mg of B2, 3 mg of B5, 0.7 mg of B6, 0.1 mg of B9, and 0.00125 mg of B12) and 200 mg of palmitoylethanolamide and 200 mg of creatine (preferably L- creatine pyruvate); 200 mg of alpha-lipoic acid (preferably R(+)-alpha-lipoic acid).

[0087] The above-described extracts can preferably be obtained using Soxhlet-type reflux extraction, particularly with ultrasound or supercritical gas methods, with the addition of sulphur dioxide as a solvent. Preferably, these extracts are obtained with Soxhlet reflux extraction method using methanol. This method involves fermenting and hydrolysing the plant part (e.g., fruit, flower, or leaf) from which the extracts are to be obtained, with the addition of yeast, preferably Saccharomycetaceae (such as Saccharomyces cerevisiae), and preferably operating at pH 7 for approximately four days; evaporation and centrifugation to remove the solvent from the solution obtained above; Soxhlet extraction; removal by heating at the boiling point of methanol and subsequent extraction by evaporation. It is noted that other methods may be adopted to achieve these extracts, preferably in a dry form, and specifically in powder form.

[0088] The mixture of active ingredients described above, and thus the composition of the invention, can take various forms of preparation depending on the desired route of administration.

[0089] The composition of the invention may be in solid form and, for example, as a tablet, capsule, powder, or granules. In this case, the preparations may include one or more vehicles such as starches, sugars, microcrystalline cellulose, and, if necessary, diluents, granulating agents, lubricants, binders, and disintegrants. Typically, tablets, pills, capsules, and granules may also contain a binder such as acacia, tragacanth gum, corn starch, or gelatine; excipients such as calcium phosphate; a disintegrant such as corn starch, potato starch, alginic acid; a lubricant such as magnesium stearate; a sweetener such as sucrose, fructose, lactose, or saccharin.

[0090] If in liquid form, it may be in the form of a suspension, emulsion, or solution. In these cases, the vehicle is liquid and may be chosen, for example, from water, glycols, oils, alcohols, and mixtures thereof.

[0091] Compositions for pharmaceutical or nutritional use can appropriately be presented in a single pharmaceutical form and prepared using any of the methods well known in pharmaceutical or food technology.

[0092] According to another aspect, the present invention relates to a method for preventing or treating neurodegenerative and / or cognitive diseases, comprising the administration to an individual of the above-described mixture of active ingredients, and therefore, the composition.

[0093] The composition for preventing and / or treating neurodegenerative and / or cognitive disorders according to the invention achieves significant advantages.

[0094] In fact, the specific mixture of active ingredients in the composition makes it possible to prevent and, above all, treat neurodegenerative disorders, particularly those affecting the brain and / or cognitive disorders, especially in patients where the disease / disorder is at an advanced stage.

[0095] As demonstrated by tests carried out by the inventor, the mixture of active ingredients, due to its content of said at least one cholinergic agent, and in particular choline bitartrate, unexpectedly promotes and significantly enhances the normal functioning of the nervous and vascular systems, combating the symptoms of cerebral aging and improving mood, concentration, and memory. These effects are synergistically supported by the other components of the mixture.

[0096] In detail, Bacopa extracts, by increasing cerebral and dendritic connections between neurons and stimulating the growth of nerve endings, support the action of the at least one cholinergic agent in combating cerebral and vascular aging and improving mood, concentration, and memory. This aspect is particularly pronounced when using choline bitartrate, which releases an extraordinarily high amount of choline that, in turn, exploits the synergy with the other active ingredients present to deliver enhanced effectiveness.

[0097] Furthermore, the presence of the cholinergic agent and particularly choline bitartrate, gives the mixture a beneficial influence on the gut microbiota, normalizing potential alterations, improving absorption, and enhancing its interconnection to the central nervous system, linking what is referred to as the "first brain" (commonly known as the brain) with the "second brain" (identified as the gastrointestinal tract). It is emphasized that this connection is also stimulated by the other active ingredients in the mixture, particularly Hericium and Cordyceps extracts and whole Hericium and Cordyceps, which positively stimulate the intestine and, consequently, the gastrointestinal tract.

[0098] At the same time, the content of Hericium (in whole form and / or extracts) increases synaptic plasticity, myelination, and neurogenesis, optimizing and improving the gut microbiota. As a result, it supports the other components of the mixture, providing strong neuroprotection, enhanced regenerative and protective activity of the nervous system, structural and functional recovery of cerebral neurons, improved memory (recognition and execution), slowing nervous and vascular system aging, and counteracting neurodegeneration. These effects have been shown to be particularly pronounced in tests when using Hericium extracts along with whole Hericium, whose integral parts demonstrated enhanced and optimized synergy with its direct extract.

[0099] The content of Cordyceps (whole and / or extracts), in conjunction with the other components of the active ingredients mixture, supports the protective effect of the composition against memory loss and neurodegenerative progression associated with the onset of diseases and / or neuro-cerebral injuries, while optimizing and improving the gut microbiota. In particular, these extracts promote the proper activation of microglial cells in the brain, stimulate the growth of new nerve cells, reduce possible neuroinflammation, and protect hippocampal tissue. Studies carried out have highlighted that, also in this case, using Cordyceps extracts with whole Cordyceps, or its integral parts, demonstrated enhanced and optimized synergy with its direct extract.

[0100] Palmitoylethanolamide, alpha-lipoic acid, and creatine (particularly creatine pyruvate, especially in its L-creatine pyruvate form) support the restoration of proper nerve transmission and vascular circulation. Consequently, they allow to assist the above-described actions of the cholinergic agent (particularly choline bitartrate), Bacopa extracts, content of whole Hericium and its extracts, and content of whole Cordyceps and its extracts, thereby further amplifying the aforementioned neurorepair processes.

[0101] All the described effects have been shown in various tests to be particularly advantageous in the neurological field, especially in patients at an advanced stage of neuro-cerebral diseases such as Alzheimer's disease.

[0102] Additionally, the described components of the active ingredients mixture, acting at the neurological, vascular, and hypothalamic levels, counteract atrophy, allowing greater motor control and thereby combating diseases such as Parkinson's. In fact, the selected active ingredients have unexpectedly demonstrated a synergistic action aimed at improving hippocampal neurotransmission, protecting brain cells, including the hippocampus, through a neuroprotective effect, and promoting the growth of new nerve cells.

[0103] Moreover, the described effects have also unexpectedly shown, in various experiments, to effectively treat brain injuries, such as those caused by stroke or head trauma, by stimulating the regeneration of damaged brain tissues. Actually, for example, in patients with acute cerebral ischemic stroke, administration of the composition described above showed slower growth of ischemic brain damage in neuroimaging analyses and accelerated recovery.

[0104] The invention is open to variations within the scope of the inventive concept defined by the claims. Within this scope, all details may be replaced with equivalent elements, and materials, shapes, and dimensions may be any.

Claims

C LAI M S1. A composition for preventing and treating neurodegenerative diseases and cognitive disorders, comprising a mixture of active ingredients, characterized in that said mixture of active ingredients comprises choline bitartrate, Bacopa, Cordyceps, and Hericium.

2. The composition according to claim 1 , wherein said Bacopa is present in the form of Bacopa extracts, said Hericium is present in the form of Hericium extracts, and said Cordyceps is present in the form of Cordyceps extracts; wherein the content of said at least choline bitartrate is substantially between 55% and 19% of the total weight of said mixture of active ingredients; wherein the content of said Bacopa extracts is substantially between 20% and 3% of said total weight of said mixture of active ingredients; wherein the content of said Cordyceps extracts is substantially between 17% and 9% of said total weight of said mixture of active ingredients; and wherein the content of said cordyceps extracts is substantially between 17% and 5% of said total weight of said mixture of active ingredients.

3. The composition according to claim 2, wherein said mixture of active ingredients comprises 1000 mg of said choline bitartrate, 250 mg of said Bacopa extracts, 300 mg of said Hericium extracts, and 300 mg of said Cordyceps extracts.

4. The composition according to any one of the preceding claims, wherein said mixture of active ingredients comprises B vitamins in a content substantially between 5.5% and 4.5% of the total weight of said mixture of active ingredients; and wherein said B vitamins exclude B3 and include at least one of B1 , B2, B5, B6, B9, and B12.

5. The composition according to any one of the preceding claims, wherein said mixture of active ingredients comprises palmitoylethanolamide and creatine.

6. The composition according to any one of the preceding claims, wherein said mixture of active ingredients comprises said Hericium in whole form; and wherein the content of whole Hericium is substantially between 15% and 10% of the total weight of said mixture of active ingredients.

7. The composition according to the preceding claim, wherein said mixture of active ingredients comprises Hericium present both in whole form and as Hericium extracts; and wherein the content of whole Hericium is substantially at least double the content of said Hericium extracts.

8. The composition according to any one of the preceding claims, wherein said mixture of active ingredients comprises said Cordyceps in whole form; and wherein the content of whole Cordyceps is substantially between 35% and 45% of the total weight of the mixture of active ingredients.

9. The composition according to the preceding claim, wherein said mixture of active ingredients comprises Cordyceps present both in whole form and as Cordyceps extracts; and wherein the content of whole Cordyceps is substantially at least double the content of said Cordyceps extracts.

10. The composition according to claims 1 , 4, 5, 6, and 7, wherein said mixture of active ingredients comprises Bacopa; wherein said mixture of active ingredients comprises 1000 mg of said choline bitartrate, 250 mg of said Bacopa extracts, 300 mg of said Hericium extracts, 700 mg of whole Hericium, 900 mg of said Cordyceps extracts, 2100 mg of whole Cordyceps, and substantially 5 mg of said B vitamins.

11. The composition according to any one of the preceding claims, wherein said mixture of active ingredients comprises palmitoylethanolamide, creatine, and alpha-lipoic acid.

12. The composition according to claims 1 , 4, 5, and 1 1 , wherein said mixture of active ingredients comprises Bacopa; wherein said mixture of active ingredients comprises 1000 mg of said choline bitartrate, 250 mg of said Bacopa extracts, 300 mg of said Hericium extracts, 700 mg of whole Hericium, 900 mg of said Cordyceps extracts, approximately 5 mg of said B vitamins, 200 mg of said palmitoylethanolamide, 200 mg of said creatine and 200 mg of said alpha-lipoic acid.