Phase II Grape Seed Extract as Anti-Oligomerization Agent in Alzheimer's Disease
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- primary safety evaluations
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Meganatural-Az Grapeseed Extract
Meganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day
Intervention: Meganatural-Az Grapeseed Extract (Drug)
Placebo
Subjects receive capsules identical in appearance to the active agent with the same incremental schedule
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
primary safety evaluations
Time Frame: up to 22 months
adverse effects reporting
pharmacokinetic analysis
Time Frame: up to 22 months
the pharmacokinetics and effects of Meganatural-Az® on tau and abnormally phosphorylated tau CSF concentrations
Secondary Outcomes
- cognitive and functional assessments(up to 22 months)
- AD Biomarkers(up to 22 months)
Investigators
Hillel Grossman
Associate Professor
Icahn School of Medicine at Mount Sinai