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Ginkgo Biloba Prevention Trial in Older Individuals

2014-08-27 03:57:09 | BioPortfolio

Summary

This study will determine the effect of 240mg/day Ginkgo biloba in decreasing the incidence of dementia and specifically Alzheimer's disease (AD), slowing cognitive decline and functional disability, reducing incidence of cardiovascular disease, and decreasing total mortality.

Description

Participants will be studied in a randomized trial of 240 mg of Ginkgo biloba as compared to placebo in healthy men and women, at least 75 years old. The trial will last approximately 8 years. The intervention will be considered unsuccessful in those participants who succumb to dementia, including Alzheimer's Disease and vascular dementia. There are four clinical centers: Pittsburgh, PA; Hagerstown, MD; Winston-Salem, NC; and Sacramento, CA; and a Coordinating Center at the University of Washington, Seattle. There will be a clinic visit every 6 months to determine morbidity, mortality and change in cognition that will include repeat of ADAS, CDR, and 10 battery neuropsychological evaluation and informant interview. The primary endpoint is dementia, specifically Alzheimer's disease, secondary endpoint will include the incidence of vascular disease, changes in cognitive function scores over time, total mortality and changes in functional status. The diagnosis of dementia will be based on neuropsychological testing, neurological exam, MRI, functional measurements, and review by a central adjudication committee and classified by DSM IV, NINCDS criteria and ADRTC criteria for vascular disease.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Conditions

Dementia

Intervention

Ginkgo biloba

Location

University of California, Davis
Sacramento
California
United States
95817

Status

Active, not recruiting

Source

National Center for Complementary and Alternative Medicine (NCCAM)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:57:09-0400

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PubMed Articles [961 Associated PubMed Articles listed on BioPortfolio]

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