- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00042172
Treatment for Early Memory Loss
Cognitive Enhancers Explored With PET Imaging
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Department of Psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Display impairment on at least 2 of 3 memory tests
- Meet the following criteria for mild cognitive impairment: subjective complaint of memory problems; no impairment in activities of daily living; general cognitive function in the normal age-adjusted range; abnormal memory function for age; and lacking full DSM criteria for dementia
Exclusion Criteria:
- Have a history of major neurological, metabolic, psychiatric or cardiovascular disease (patients with a history of non-CNS oncologic disease treated surgically and currently in remission will not be excluded)
- Have a cerebrovascular condition
- Abuse alcohol or drugs
- Have renal or hepatic disease, diabetes mellitus, gout, or adrenocortical insufficiency
- Are sensitive to carbonic anhydrase inhibitors, antibacterial sulfonamides, thiazide diuretics, or other sulfonamide-derivative diuretics
- Have taken donepezil or GBE products prior to enrollment
- Have taken medications, including herbal agents (exceptions will be made for routine health maintenance medications such as alendronate [Fosamax] for osteoporosis, vitamin therapy [not to exceed 200 percent RDA for any particular vitamin], thyroid replacement therapy, hormone replacement, and ophthalmic medications for glaucoma and other eye disorders)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Alzheimer Disease
- Cognition Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Donepezil
Other Study ID Numbers
- R21MH061801 (U.S. NIH Grant/Contract)
- DSIR AT-GP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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