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Treatment for Early Memory Loss

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00042172
First received: July 24, 2002
Last updated: November 17, 2005
Last verified: May 2005
History of Changes
  Purpose

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
Cognition Disorders
Alzheimer Disease
 Drug: Donepezil
Drug: Ginkgo Biloba Extract
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Cognitive Enhancers Explored With PET Imaging

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 40
Study Start Date: June 2002
Estimated Study Completion Date: September 2004
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042172

Locations
United States, Iowa
University of Iowa Department of Psychiatry
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00042172     History of Changes
Other Study ID Numbers: R21 MH61801, DSIR AT-GP
Study First Received: July 24, 2002
Last Updated: November 17, 2005
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Cognition
Memory

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
 Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013