Healthy Aging and Memory Study

Alzheimer Disease Clinical Trial

Official title:

Alzheimer's Disease Prevention Instrument Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00034567
• Other study ID #: IA0032
• Status: Completed
• Phase: N/A
• First received: April 30, 2002
• Last updated: September 14, 2007

Study information

• Verified date: September 2007
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 75 Years and older

Eligibility

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 0.5.

• 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

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Alzheimer Disease

Locations

Country	Name	City	State
United States	Michigan Alzheimer's Disease Research Center	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama, Birmingham	Birmingham	Alabama
United States	Baumel-Eisner Neuromedical Institute, Boca Raton	Boca Raton	Florida
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Rush Alzheimer's Disease Center	Chicago	Illinois
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Baumel-Eisner Ft Lauderdale	Ft Lauderdale	Florida
United States	Indiana University Alzheimer's Center	Indianapolis	Indiana
United States	University of California, Irvine	Irvine	California
United States	Mayo Clinic, Jacksonville	Jacksonville	Florida
United States	University of California, San Diego	La Jolla	California
United States	University of Nevada, Las Vegas	Las Vegas	Nevada
United States	University of Kentucky, Lexington	Lexington	Kentucky
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	Baumel-Eisner Neuromedical Institute, Miami Beach	Miami Beach	Florida
United States	Wien Center for Memory Disorders	Miami Beach	Florida
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Columbia University	New York	New York
United States	Mt. Sinai Medical Center	New York	New York
United States	New York University School of Medicine	New York	New York
United States	Medical University of South Carolina	North Charleston	South Carolina
United States	Stanford/Va Aging Clinical Research Center	Palo Alto	California
United States	Memorial Hospital of Rhode Island (Brown University)	Pawtucket	Rhode Island
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health Sciences University	Portland	Oregon
United States	Mayo Alzheimer's Disease Center	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	University of California, Davis	Sacramento	California
United States	Washington University	St. Louis	Missouri
United States	Sun Health Research Institute	Sun City	Arizona
United States	University of South Florida, Tampa	Tampa	Florida
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (7)

Cummings JL, Raman R, Ernstrom K, Salmon D, Ferris SH; Alzheimer's Disease Cooperative Study Group. ADCS Prevention Instrument Project: behavioral measures in primary prevention trials. Alzheimer Dis Assoc Disord. 2006 Oct-Dec;20(4 Suppl 3):S147-51. — View Citation

Ferris SH, Aisen PS, Cummings J, Galasko D, Salmon DP, Schneider L, Sano M, Whitehouse PJ, Edland S, Thal LJ; Alzheimer's Disease Cooperative Study Group. ADCS Prevention Instrument Project: overview and initial results. Alzheimer Dis Assoc Disord. 2006 O — View Citation

Galasko D, Bennett DA, Sano M, Marson D, Kaye J, Edland SD; Alzheimer's Disease Cooperative Study. ADCS Prevention Instrument Project: assessment of instrumental activities of daily living for community-dwelling elderly individuals in dementia prevention — View Citation

Patterson MB, Whitehouse PJ, Edland SD, Sami SA, Sano M, Smyth K, Weiner MF; Alzheimer's Disease Cooperative Study Group. ADCS Prevention Instrument Project: quality of life assessment (QOL). Alzheimer Dis Assoc Disord. 2006 Oct-Dec;20(4 Suppl 3):S179-90. — View Citation

Sano M, Zhu CW, Whitehouse PJ, Edland S, Jin S, Ernstrom K, Thomas RG, Thal LJ, Ferris SH; Alzheimer Disease Cooperative Study Group. ADCS Prevention Instrument Project: pharmacoeconomics: assessing health-related resource use among healthy elderly. Alzhe — View Citation

Schneider LS, Clark CM, Doody R, Ferris SH, Morris JC, Raman R, Reisberg B, Schmitt FA. ADCS Prevention Instrument Project: ADCS-clinicians' global impression of change scales (ADCS-CGIC), self-rated and study partner-rated versions. Alzheimer Dis Assoc D — View Citation

Walsh SP, Raman R, Jones KB, Aisen PS; Alzheimer's Disease Cooperative Study Group. ADCS Prevention Instrument Project: the Mail-In Cognitive Function Screening Instrument (MCFSI). Alzheimer Dis Assoc Disord. 2006 Oct-Dec;20(4 Suppl 3):S170-8. — View Citation

External Links

•   UCSD Alzheimer's Disease Cooperative Study