Phase 2 Study to Examine Grape Seed Extract as an Anti-Oligomerization Agent in Alzheimer's Disease (AD)

Study Overview
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Brief Summary
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Alzheimer Disease (AD) is a progressive brain disease generally known as senile dementia. Our proposed study will establish safety and pharmacokinetics of Meganatural-AZ GSPE in AD subjects. As secondary measures, we will also provide the essential human data to guide the design of future studies to test the efficacy of GSPE in mitigating cognitive deterioration in AD patients.

Detailed Description
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This study aims to establish the safety and pharmacokinetics of Meganatural-Az® GSPE in subjects with Alzheimer's disease. As a secondary goal, clinical and biomarker indices of therapeutic efficacy will also be evaluated. The proposed study will provide the essential human data necessary to guide the design of future studies testing the efficacy of GSPE in mitigating cognitive deterioration in AD patients.

Official Title
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Phase II Grape Seed Extract as Anti-Oligomerization Agent in Alzheimer's Disease

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: Meganatural-Az Grapeseed Extract
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NINCDS/ADRDA criteria for probable AD MMSE between 12-26 Treatment with a cholinesterase inhibitor or an NMDA (N-methyl-D-asparate) antagonist with stable dose for at least 12 weeks Home monitoring available for supervision of medications Caregiver available to accompany patient to all visits and willing to participate in study as informant Fluent in English or Spanish Medical stability for this study as confirmed by review of records, internist's physical exam, neurological exam, and laboratory tests Stable doses of non-excluded medication No evidence of hepatic insufficiency Able to swallow oral medications Ability to participate in the informed consent process Exclusion Criteria: History of hypotension or unstable hypertension Active hepatic or renal disease Use of another investigational drug within the past two months History of clinically significant stroke History of seizure or head trauma with disturbance of consciousness within the past two years Major mental illness including psychotic disorders, bipolar disorder, or major depressive episode that is not in remission for less than 12 months Women of child-bearing age unless using effective birth control or at least one year post-menopausal or surgically menopausal Any ferrous or metallic materials which are contraindicated for MRI Medication Exclusions Current use of drugs with significant anticholinergic or antihistaminic properties
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Meganatural-Az Grapeseed Extract<br>Meganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day | Drug: Meganatural-Az Grapeseed Extract<br>* Meganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day<br>* Other names: GSPE;|
| Placebo Comparator: Placebo<br>Subjects receive capsules identical in appearance to the active agent with the same incremental schedule | Drug: Placebo<br>* Subjects receive capsules identical in appearance to the active agent with the same incremental schedule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic analysis | the pharmacokinetics and effects of Meganatural-Az® on tau and abnormally phosphorylated tau CSF concentrations | up to 22 months | 
| primary safety evaluations | adverse effects reporting | up to 22 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AD Biomarkers | β-amyloid (Aβ) in plasma and in cerebral spinal fluid (CSF) specimens | up to 22 months | 
| cognitive and functional assessments | cognitive and functional assessments including the ADAS-cog, ADCS CGIC, MMSE, and ADL. | up to 22 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 2, Alzheimer's Disease, Grapeseed Extract, Clinical Trial, Meganatural-AZ, anti-oligomerization, Dietary Supplement, Nutraceutical