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Home > "G" Clinical Trials Conditions > Ginkgo Biloba Prevention Trial in Older Individuals Ginkgo Biloba Prevention Trial in Older Individuals
Ginkgo Biloba Prevention Trial in Older Individuals
For Condition: Alzheimer's Disease,Dementia
Status: No longer recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: 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.
Details: 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 5 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, neuro exam, MRI, functional measurements, and review by a central adjudication committee and classified by DSM IV, NINCDS criteria and ADRTC criteria for vascular disease.
Eligibility:
Study Type: Interventional, Prevention, Randomized
Minimum Age/Maximum Age: 75 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Non-demented participants - Willing to participate in a six-year follow-up trial of Ginkgo Biloba - English is their usual language - Willing informant who has frequent contact with the participant Exclusion Criteria: - Currently on anticoagulant therapy - Cancer diagnosed and treated within the past two years (except for skin cancer) - Participant with class III - IV congestive heart failure - Currently being treated with psychopharmacological drugs for depression - Hospitalized for depression within the last year - Taking Aricept (or similar agents) for cognitive problems or dementia - Baseline blood creatinine >2 - Baseline SGGT is a marker of liver function (3 x normal>or=90 IU) - Baseline hematocrit<30 - Baseline white blood count>or=15,000
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenDeKosky, Principal Investigator, University of Pittsburgh, Department of Neurology
Wake Forest University School of Medicine
Winston Salem, North Carolina, 27157-1063
United States
University of California, Davis
Sacramento, California, 95817
United States
Johns Hopkins University
Hagerstown, Maryland,
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
United States
Additional Information:
Study ID Numbers: 1 U01 AT00162-01M; 1 U01 AT00162-01
Study Start Date: April 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010803
Other Dementia Studies:
1. VITAL - VITamins to slow ALzheimer's disease (Homocysteine Study)
2. Genetic Studies in Alzheimer's Disease
3. Prevention of cognitive decline in Alzheimer's disease by ingested interferon alpha
4. Nurse Managed Clinic for Dementia Patients and Family Caregivers
5. Brain Imaging in Elderly People and Individuals with Alzheimer's Disease
Related Studies:
Other Dementia Clinical Trials
Other California Clinical Trials
Other Sacramento Clinical Trials
Ginkgo Biloba Prevention Trial in Older Individuals
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