Alzheimer's Disease Prevention Instrument Protocol

National Institute on Aging (NIA)39 sites in 1 country650 target enrollmentMay 1, 2002

ConditionsAlzheimer Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Alzheimer Disease
Sponsor: National Institute on Aging (NIA)
Enrollment: 650
Locations: 39
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This project will focus on the development and testing of efficient, cost effective measures that are specifically designed for use in Alzheimer's Disease (AD) primary prevention trials.

Detailed Description

This project will focus on the development and testing of efficient, cost effective measures that are specifically designed for use in AD primary prevention trials. The new or improved measures that have been developed will then be evaluated in 650 nondemented subjects enrolled in a simulated Alzheimer's disease prevention trial. Once enrolled, subjects will be followed for four years with annual clinical evaluations and interim six-month phone calls.

Registry

clinicaltrials.gov

Start Date

May 1, 2002

End Date

TBD

Last Updated

18 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

National Institute on Aging (NIA)

Eligibility Criteria

Inclusion Criteria

•75 years or older.
•Fluent in English or Spanish.
•Stable medical condition for four weeks prior to screening visit.
•Stable medications for four weeks prior to screening visit.
•Either cognitively normal, or mild cognitive impairment. If MCI, the subject's CDR at screening have a global score of 0.
•mMMSE score greater than 88 for subjects with at least 8 years education, or greater than 80 for subjects with less than 8 years education, and FCSRT total free plus cued recall score greater than 44 with 3 learning trials.
•Willing to participate in four to five year follow-up study.
•Willing to identify person who can serve as informant.
•At least six years education or work history sufficient to exclude mental retardation

Exclusion Criteria

•Meets DSM IV criteria for dementia
•History of clinically significant medical illness that would interfere with participation in trial, including active malignancy, myocardial infarction, or cerebrovascular accident within the past year
•Alcohol or substance abuse and/or active major psychiatric disorders
•Concurrent participation in a clinical drug trial
•History of mental retardation