Phase 2 Study to Examine Grape Seed Extract as an Anti-Oligomerization Agent in Alzheimer's Disease (AD)
NCT ID: NCT02033941
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
10 participants
INTERVENTIONAL
2018-07-03
2019-10-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Meganatural-Az Grapeseed Extract
Meganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day
Meganatural-Az Grapeseed Extract
Meganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day
Placebo
Subjects receive capsules identical in appearance to the active agent with the same incremental schedule
Placebo
Subjects receive capsules identical in appearance to the active agent with the same incremental schedule
Interventions
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Meganatural-Az Grapeseed Extract
Meganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day
Placebo
Subjects receive capsules identical in appearance to the active agent with the same incremental schedule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Hillel Grossman
OTHER
Responsible Party
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Hillel Grossman
Associate Professor
Principal Investigators
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Hillel Grossman, MD
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai School of Medcine
Samuel Gandy, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Mount Sinai Alzheimer's Disease Research Center
New York, New York, United States
Countries
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Other Identifiers
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GCO 09-0307
Identifier Type: -
Identifier Source: org_study_id
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