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Treatment for Early Memory Loss

Primary Purpose

Cognition Disorders, Alzheimer Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Donepezil
Ginkgo Biloba Extract
Sponsored by
University of Iowa
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognition Disorders focused on measuring Cognition, Memory

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Iowa Department of Psychiatry

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 24, 2002
Last Updated
February 27, 2014
Sponsor
University of Iowa
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00042172
Brief Title
Treatment for Early Memory Loss
Official Title
Cognitive Enhancers Explored With PET Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Iowa
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognition Disorders, Alzheimer Disease
Keywords
Cognition, Memory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Donepezil
Intervention Type
Drug
Intervention Name(s)
Ginkgo Biloba Extract

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
University of Iowa Department of Psychiatry
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

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Treatment for Early Memory Loss

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