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

Hillel Grossman

Status and phase: Terminated; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: Meganatural-Az Grapeseed Extract; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02033941

5R21AT005510 (U.S. NIH Grant/Contract)

GCO 09-0307

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups, including a placebo group

Meganatural-Az Grapeseed Extract

Active Comparator group

Description:

Meganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day

Treatment:

Drug: Meganatural-Az Grapeseed Extract

Placebo

Placebo Comparator group

Description:

Subjects receive capsules identical in appearance to the active agent with the same incremental schedule

Treatment:

Drug: Placebo