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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00042172 |
The purpose of this study is to evaluate the effectiveness of donepezil (Aricept) for the treatment of mild cognitive impairment (MCI) in elderly adults. This study will also determine whether adding ginkgo biloba extract (GBE) enhances the effects of donepezil.
Condition | Intervention | Phase |
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Cognition Disorders Alzheimer Disease |
Drug: Donepezil Drug: Ginkgo Biloba Extract |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Cognitive Enhancers Explored With PET Imaging |
Estimated Enrollment: | 40 |
Study Start Date: | June 2002 |
Estimated Study Completion Date: | September 2004 |
Cognition involves important thinking processes such as perception, learning, and reasoning. There are currently no definitive treatments for cognitive deterioration. This study focuses on elderly individuals with MCI because people at a pre-dementia stage may sustain the greatest and most lasting benefit from cognitive-enhancing agents.
Patients receive either donepezil or placebo for the first 6 months of the study. In the second 6 months of the study, patients are randomized to receive either donepezil plus GBE or donepezil alone. Positron Emission Tomography (PET), which provides a color-coded image of the brain's blood flow in a particular area, is used to assess brain activity during memory tasks. A PET scan is performed at study entry, 6 months, and 1 year. A vasodilator (a drug that dilates the blood vessels) is administered during the PET imaging procedure to determine whether vascular disease affects memory function. A magnetic resonance imaging (MRI) scan is also taken to view the brain.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | R21 MH61801, DSIR AT-GP |
Study First Received: | July 24, 2002 |
Last Updated: | November 17, 2005 |
ClinicalTrials.gov Identifier: | NCT00042172 |
Health Authority: | United States: Federal Government |
Cognition Memory |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Donepezil Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Cognition Disorders Amnesia Delirium |
Nervous System Diseases Tauopathies |