Working… Menu

Treatment for Early Memory Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00042172
Recruitment Status : Completed
First Posted : July 26, 2002
Last Update Posted : March 3, 2014
National Institute of Mental Health (NIMH)
Information provided by:
University of Iowa

Brief Summary:
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 or disease Intervention/treatment Phase
Cognition Disorders Alzheimer Disease Drug: Donepezil Drug: Ginkgo Biloba Extract Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Cognitive Enhancers Explored With PET Imaging
Study Start Date : June 2002
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
Drug Information available for: Donepezil

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00042172

Layout table for location information
United States, Iowa
University of Iowa Department of Psychiatry
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
National Institute of Mental Health (NIMH)
Layout table for additonal information Identifier: NCT00042172    
Other Study ID Numbers: R21MH061801 ( U.S. NIH Grant/Contract )
R21MH061801 ( U.S. NIH Grant/Contract )
First Posted: July 26, 2002    Key Record Dates
Last Update Posted: March 3, 2014
Last Verified: February 2014
Keywords provided by University of Iowa:
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents