NCT02033941

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Hillel Grossman · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer's Disease

Interventions

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

Timeline

• Start date: 2018-07-03
• Primary completion: 2019-10-04
• Completion: 2019-10-04
• First posted: 2014-01-13
• Last updated: 2024-10-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study