A Phase 2 interventional study of Meganatural-Az Grapeseed Extract and Placebo in Alzheimer's Disease, sponsored by Hillel Grossman. Terminated at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Hillel Grossman · Phase 2, Interventional, and Treatment
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.
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.
This study's enrollment of 10 is below the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →This is the only study on the registry with Hillel Grossman as lead sponsor.
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Exclusion Criteria:
Medication Exclusions
Meganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day
Drug: Meganatural-Az Grapeseed Extract
Subjects receive capsules identical in appearance to the active agent with the same incremental schedule
Drug: Placebo
Meganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day
Also known as: Grapeseed Polyphenolic Extract, Grapeseed Phenol Extract, GSPE
Subjects receive capsules identical in appearance to the active agent with the same incremental schedule
pharmacokinetic analysis
the pharmacokinetics and effects of Meganatural-Az® on tau and abnormally phosphorylated tau CSF concentrations
Time frame: up to 22 months
primary safety evaluations
adverse effects reporting
Time frame: up to 22 months
AD Biomarkers
β-amyloid (Aβ) in plasma and in cerebral spinal fluid (CSF) specimens
Time frame: up to 22 months
cognitive and functional assessments
cognitive and functional assessments including the ADAS-cog, ADCS CGIC, MMSE, and ADL.
Time frame: up to 22 months
Plan to share: No
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This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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