Clinical trial NCT00034567: Healthy Aging and Memory Study
Official title: Alzheimer's Disease Prevention Instrument Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Keywords: Prevention
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
First posted: 2002-05-01
Enrollment: 650
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

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.

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 0.5.
* 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: Sun City
country: United States
facility: Sun Health Research Institute
state: Arizona
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Palo Alto
country: United States
facility: Stanford/Va Aging Clinical Research Center
state: California
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Boca Raton
country: United States
facility: Baumel-Eisner Neuromedical Institute, Boca Raton
state: Florida
city: Ft Lauderdale
country: United States
facility: Baumel-Eisner Ft Lauderdale
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic, Jacksonville
state: Florida
city: Miami Beach
country: United States
facility: Wien Center for Memory Disorders
state: Florida
city: Miami Beach
country: United States
facility: Baumel-Eisner Neuromedical Institute, Miami Beach
state: Florida
city: Tampa
country: United States
facility: University of South Florida, Tampa
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush Alzheimer's Disease Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Alzheimer's Center
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky, Lexington
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Alzheimer's Disease Research Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Alzheimer's Disease Center
state: Minnesota
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Las Vegas
country: United States
facility: University of Nevada, Las Vegas
state: Nevada
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: Mt. Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Pawtucket
country: United States
facility: Memorial Hospital of Rhode Island (Brown University)
state: Rhode Island
city: North Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: NYU Langone Health
name: Steven H. Ferris, PhD
role: STUDY_DIRECTOR
References:
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 Oct-Dec;20(4 Suppl 3):S109-23. doi: 10.1097/01.wad.0000213870.40300.21.
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 Disord. 2006 Oct-Dec;20(4 Suppl 3):S124-38. doi: 10.1097/01.wad.0000213878.47924.44.
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 clinical trials. Alzheimer Dis Assoc Disord. 2006 Oct-Dec;20(4 Suppl 3):S152-69. doi: 10.1097/01.wad.0000213873.25053.2b.
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. Alzheimer Dis Assoc Disord. 2006 Oct-Dec;20(4 Suppl 3):S191-202. doi: 10.1097/01.wad.0000213875.63171.87.
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. doi: 10.1097/01.wad.0000213879.55547.57.
citation: 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. doi: 10.1097/01.wad.0000213872.17429.0f.
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. doi: 10.1097/01.wad.0000213874.25053.e5.