Clinical trial NCT02033941: Phase 2 Study to Examine Grape Seed Extract as an Anti-Oligomerization Agent in Alzheimer's Disease (AD)
Official title: Phase II Grape Seed Extract as Anti-Oligomerization Agent in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Grapeseed Extract
Clinical Trial
Meganatural-AZ
anti-oligomerization
Phase 2
Dietary Supplement
Nutraceutical
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2014-01-13
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: pharmacokinetic analysis
timeFrame: up to 22 months
measure: primary safety evaluations
timeFrame: up to 22 months
Secondary outcomes:
measure: AD Biomarkers
timeFrame: up to 22 months
measure: cognitive and functional assessments
timeFrame: up to 22 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Alzheimer's Disease Research Center
state: New York
Study officials:
affiliation: Mount Sinai School of Medcine
name: Hillel Grossman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Samuel Gandy, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: