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Home > "P" Clinical Trials Conditions > Preventing Cognitive Decline with Alternative Therapies  Preventing Cognitive Decline with Alternative Therapies
Preventing Cognitive Decline with Alternative Therapies
For Condition: Dementia,Memory Disorders
Status: No longer recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: Preventing dementia is an important goal for our aging population. This proposal is an initial 42 months study of the effect of standardized ginkgo biloba extract (GBE) on preventing or delaying cognitive decline in people age 85 years or older (the oldest old). The study focuses on the oldest old who present a distinct advantage for primary prevention studies because of their particularly high risk for developing mild cognitive impairment (MCI), a precursor to dementia. Because this is a population that has previously been out of the mainstream for use of alternative medicine, the safety of GBE in this age group will also be tested in this study. The study is randomized, placebo controlled and double blind. Approximately 200 elderly cognitively healthy subjects will be enrolled and followed for detection of conversion to MCI. This pilot study is viewed as a necessary first step in order to demonstrate that GBE, an alternative or complementary therapy, has a disease modifying effect on the brain, distinct from a symptomatic effect. The study will test the feasibility of the randomized start design, a trial design proposed as a method for discerning brain- or disease- modifying from symptomatic effects. The magnitude of biological effect of the treatments will also be assessed with volumetric quantitative MRI, a complementary means of confirming whether there is a brain modifying effect (measured as a decrease in brain volume loss with treatment). Peripheral markers of oxidation status will measure possible anti-oxidant effects of GBE.
Details:
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 85 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Can identify a collateral informant who has frequent contact with the subject - No memory complaints compared to others of same age group and has not sought attention for concerns about memory or cognition - Normal memory function defined by an education-adjusted score on the Logical Memory Subscale of the Wechsler Memory Scale-Revised - Mini-Mental State Examination Score >23 - Clinical Dementia Rating (CDR) of zero
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Dr.Kaye, Principal Investigator, Oregon Health and Science University
Oregon Health Sciences University/Neurology
Portland, Oregon, 97201
United States
Additional Information:
Study ID Numbers: 1 P50 AT00066-01P2; 1 P50 AT00066-01
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010920
Other Memory Disorders Studies:
1. Preventing Cognitive Decline with Alternative Therapies
2. Alzheimer's Disease Prevention Trial
3. AIT-082 Phase 1B Study
4. Anti-Inflammatory Treatment for Age-Associated Memory Impairment: A Double-Blind Placebo-Controlled Trial
5. Prevention of cognitive decline in Alzheimer's disease by ingested interferon alpha
Related Studies:
Other Memory Disorders Clinical Trials
Other Oregon Clinical Trials
Other Portland Clinical Trials
Preventing Cognitive Decline with Alternative Therapies
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