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Memory Impairment Study (Mild Cognitive Impairment Study)

NCT00000173 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2009-12-11

No results posted yet for this study

Summary

The National Institute on Aging (NIA) is launching a nationwide treatment study targeting individuals with mild cognitive impairment (MCI), a condition characterized by a memory deficit, but not dementia. An NIA-funded study recently confirmed that MCI is different from both dementia and normal age-related changes in memory. Accurate and early evaluation and treatment of MCI individuals might prevent further cognitive decline, including development of Alzheimer's disease (AD).

The Memory Impairment Study is the first such AD prevention clinical trial carried out by NIH, and will be conducted at 65-80 medical research institutions located in the United States and Canada. This study will test the usefulness of two drugs to slow or stop the conversion from MCI to AD. The trial will evaluate placebo, vitamin E, and donepezil, an investigational agent approved by the Food and Drug Administration for another use. Vitamin E (alpha-tocopherol) is thought to have antioxidant properties, and was shown in a 1997 study to delay important dementia milestones, such as patients' institutionalization or progression to severe dementia, by about seven months.

Conditions

  • Alzheimer Disease

Interventions

DRUG

Donepezil

DRUG

Vitamin E

Sponsors & Collaborators

  • Alzheimer's Disease Cooperative Study (ADCS)

    collaborator OTHER

  • National Institute on Aging (NIA)

    lead NIH

Principal Investigators

  • Leon Thal, MD · Alzheimer's Disease Cooperative Study

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-03-31
Primary Completion
2004-01-31
Completion
2004-01-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000173 on ClinicalTrials.gov