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Methods and compositions for improving cognitive function

A composition and hydrate technology, applied in the direction of drug combination, heterocyclic compound active ingredients, pharmaceutical formulations, etc., can solve the problems of limited usefulness of donepezil

Inactive Publication Date: 2015-12-09
AGENEBIO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Alzheimer's patients on donepezil show mild cognitive improvement (Barner et al., 1998; Rogers et al., 1998), but the usefulness of donepezil is limited by its moderate efficacy and side effects

Method used

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  • Methods and compositions for improving cognitive function
  • Methods and compositions for improving cognitive function
  • Methods and compositions for improving cognitive function

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[3846] Example 1: Behavioral evaluation of levetiracetam, donepezil and combination therapy in the radial arm maze task

[3847] Aged, male Long-Evans rats were obtained from Charles River Laboratories (Raleigh, NC) at the age of 8 to 9 months, and were kept in an animal shelter until they were 24 to 26 months old. All rats were individually reared at 25°C and maintained a 12-hour light / dark cycle. Unless otherwise specified, eat and drink at will. The health and pathogen-free status of the rats throughout the experiment were checked, and an autopsy was performed when sacrificed.

[3848] All rats were screened by standardized evaluation of spatial cognition. This background evaluation used the well-established MWM scheme described above. The aged rats that proved to have impaired memory performance in the standardized evaluation of spatial cognition, namely, AI rats, were selected for drug intervention research. Under the following different drug / control treatment conditions, ...

Embodiment 2

[3863] Example 2: Levetiracetam treatment in human subjects with aMCI

[3864] An 8-week in-subject trial involving 17 low-dose levetiracetam, amnestic MCI (aMCI) subjects and 17 age-matched controls was conducted. During the study period, each aMCI subject received drug and placebo treatment in two cycles of each two weeks, so that the order of treatment was balanced among different aMCI subjects (see image 3 ). An age-matched control subject treated with a placebo was used as another control. Cognitive tests and fMRI imaging data were obtained from the subjects after each two-week cycle of drug / placebo treatment.

[3865] Participants and clinical characterization

[3866] 17 right-handed aMCI patients were recruited from the Alzheimer's Disease Research Center (ADRC) and other referrals at JohnsHopkins Hospital. Another 17 right-handed healthy volunteers were recruited from the control participant pool of ADRC and other referral institutions. Conduct a telephone consultation ...

Embodiment 3

[3894] Example 3: The effect of levetiracetam in subjects with aMCI

[3895] An 8-week in-subject trial involving 38 subjects with amnestic MCI (aMCI) and 17 age-matched controls treated with low-dose levetiracetam. During the study period, each aMCI subject received drug and placebo treatment in two cycles of each two weeks, so that the order of treatment was balanced among different aMCI subjects (see Figure 7 ). An age-matched control subject treated with a placebo was used as another control. Cognitive tests and fMRI imaging data were obtained from subjects after each two-week cycle of drug / placebo treatment.

[3896] Participants and clinical characterization

[3897] 38 right-handed aMCI patients were recruited from the Alzheimer's Disease Research Center (ADRC) and other referrals at Johns Hopkins Hospital. Another 17 right-handed healthy volunteers were recruited from the control participant pool of ADRC and other referral institutions. Conduct a telephone consultation o...

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Abstract

The invention relates to compositions comprising a synaptic vesicle glycoprotein 2A (SV2A) inhibitor in an extended release and an acetylcholinesterase inhibitor (AChEIs). The invention also relates to using such compositions in treating cognitive impairment associated with central nervous system disorders in a subject in need or at risk thereof, including, without limitation, subjects having or at risk for age-related cognitive impairment, Mild Cognitive Impairment (MCI), dementia, Alzheimer's Disease(AD), prodromal AD, post traumatic stress disorder (PTSD), schizophrenia, bipolar disorder, amyotrophic lateral sclerosis (ALS), cancer-therapy-related cognitive impairment, mental retardation, Parkinson's disease (PD), autism, compulsive behavior, and substance addiction.

Description

[0001] Related application [0002] This application claims priority and rights from US Provisional Patent Application 61 / 800,191 (filed on March 15, 2013), the content and disclosure of which are fully incorporated herein by reference. Invention field [0003] The present invention relates to methods and compositions for improving cognitive function by using a combination of a synaptic vesicle protein 2A (SV2A) inhibitor and an acetylcholinesterase inhibitor (AChEI). Specifically, it relates to a composition in a sustained-release form comprising a combination of an SV2A inhibitor and AChEI and its use in the treatment of cognitive impairment associated with central nervous system (CNS) disorders in a subject, the subject The person is in need or is at risk of suffering from the disorder, including, without limitation, suffering from or suffering from age-related cognitive impairment, mild cognitive impairment (MCI), amnestic MCI (aMCI), Age-related memory impairment (AAMI), age-...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/13
CPCA61K31/662A61K31/27A61K31/4015A61K31/445A61K31/55A61P21/00A61P25/00A61P25/16A61P25/18A61P25/28A61P25/30A61P35/00A61P43/00A61K2300/00
Inventor G·史密斯
Owner AGENEBIO
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