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Grape Seed Extract for Alzheimer's Disease

Recruiting

This Phase II clinical trial will establish the safety and pharmacokinetics of a grape seed extract, Meganatural-Az, and test its effects on cognition in people with Alzheimer's disease. This extract is thought to act on tau tangles, a protein accumulation seen in the brain of people with Alzheimer's.

Minimum Age Maximum Age Gender Healthy Volunteers
N/A N/A Both No
November 2014
September 2020
20

  • Meets NINCDS/ADRDA criteria for probable Alzheimer's disease
  • Mini-Mental State Examination score of 12-26
  • Treatment with an approved Alzheimer's medication with stable dose for at least 12 weeks
  • Able to swallow oral medications; home monitoring available for supervision of medications
  • Caregiver available to accompany participant to all visits and participate in study as informant
  • Fluent in English or Spanish
  • Medical stability, as confirmed by review of records, physical exam, neurological exam, and laboratory tests

  • History of hypotension (low blood pressure) or unstable hypertension (high blood pressure)
  • Active hepatic or renal disease; hepatic insufficiency
  • Use of another investigational drug within the past 2 months
  • History of clinically significant stroke
  • Seizure or head trauma with disturbance of consciousness within the past 2 years
  • Major mental illness, including psychotic disorders, bipolar disorder, or major depressive episode, that is not in remission for less than 12 months
  • Women must use effective birth control or be at least 1 year postmenopausal or surgically menopausal
  • Any ferrous or metallic materials that preclude magnetic resonance imaging
  • Current use of drugs with significant anticholinergic or antihistaminic properties

Participants will be randomly assigned to take grape seed polyphenolic extract or a placebo as a capsule, starting with 30 mg/day for 2 weeks, then 600 mg/day for 4 weeks, and 1,000 mg/day for another 4 weeks.

Name City State Zip Status Primary Contact
Mount Sinai Alzheimer's Disease Research Center
New York New York 10029 Recruiting Yoni Greenberg, BA
212-659-5621
jonathan.greenberg@mssm.edu

Hillel Grossman, MD

  • National Center for Complementary and Integrative Health (NCCIH)

Name Role Affiliation
Hillel Grossman, MD Principal Investigator Icahn School of Medicine at Mount Sinai
Samuel Gandy, MD/PhD Principal Investigator Icahn School of Medicine at Mount Sinai

Name Phone Email
Yoni Greenberg, BA 212-659-5621 jonathan.greenberg@mssm.edu

NCT02033941

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