NCT00010803

Ginkgo Biloba Prevention Trial in Older Individuals

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,069 (actual)
• Sponsor: National Center for Complementary and Integrative Health (NCCIH) · NIH
• Sex: All
• Age: 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Dementia
• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Ginkgo biloba	120mg twice a day
DRUG	Placebo	One pill twice daily

Timeline

• Start date: 2000-10-01
• Primary completion: 2008-04-01
• Completion: 2011-07-01
• First posted: 2001-02-05
• Last updated: 2013-03-14
• Results posted: 2010-09-16

Locations

5 sites across 1 country: United States