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

Phase 2

Terminated

• Conditions: Alzheimer's Disease
• Interventions: Drug: Placebo; Drug: Meganatural-Az Grapeseed Extract

• Registration Number: NCT02033941
• Lead Sponsor: Hillel Grossman

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-01-09
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-13
• Study Start: 2018-07-03
• Primary Completion: 2019-10-04
• Study Completion: 2019-10-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects receive capsules identical in appearance to the active agent with the same incremental schedule
Meganatural-Az Grapeseed Extract	Meganatural-Az Grapeseed Extract	Meganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day

Primary Outcome Measures

Name	Time	Method
primary safety evaluations	up to 22 months	adverse effects reporting
pharmacokinetic analysis	up to 22 months	the pharmacokinetics and effects of Meganatural-Az® on tau and abnormally phosphorylated tau CSF concentrations

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mount Sinai Alzheimer's Disease Research Center; 🇺🇸 New York, New York, United States