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Healthy Aging and Memory Study
This study has been completed.
First Received: April 30, 2002   Last Updated: September 14, 2007   History of Changes
Sponsor: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00034567
  Purpose

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.


Condition
Alzheimer Disease

Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Prospective Study
Official Title: Alzheimer's Disease Prevention Instrument Protocol

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment: 650
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

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00034567

  Hide Study Locations
Locations
United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294-1150
United States, Arizona
Sun Health Research Institute
Sun City, Arizona, United States, 85351
United States, California
University of California, San Diego
La Jolla, California, United States, 92037
University of Southern California
Los Angeles, California, United States, 90033-1039
Stanford/Va Aging Clinical Research Center
Palo Alto, California, United States, 94304
University of California, Irvine
Irvine, California, United States, 92697-4285
University of California, Los Angeles
Los Angeles, California, United States, 90095-1769
University of California, Davis
Sacramento, California, United States, 95817
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
Baumel-Eisner Ft Lauderdale
Ft Lauderdale, Florida, United States, 33321
Baumel-Eisner Neuromedical Institute, Boca Raton
Boca Raton, Florida, United States, 33486
Baumel-Eisner Neuromedical Institute, Miami Beach
Miami Beach, Florida, United States, 33154
University of South Florida, Tampa
Tampa, Florida, United States, 33617
Wien Center for Memory Disorders
Miami Beach, Florida, United States, 33140
Mayo Clinic, Jacksonville
Jacksonville, Florida, United States, 32224
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
United States, Illinois
Rush Alzheimer's Disease Center
Chicago, Illinois, United States, 60612
Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University Alzheimer's Center
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Kentucky, Lexington
Lexington, Kentucky, United States, 40506
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287-7218
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
United States, Michigan
Michigan Alzheimer's Disease Research Center
Ann Arbor, Michigan, United States, 48109-2007
United States, Minnesota
Mayo Alzheimer's Disease Center
Rochester, Minnesota, United States, 55901
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63108
United States, Nevada
University of Nevada, Las Vegas
Las Vegas, Nevada, United States, 89102
United States, New York
University of Rochester
Rochester, New York, United States, 14620
Columbia University
New York, New York, United States, 10032
Mt. Sinai Medical Center
New York, New York, United States, 10029
New York University School of Medicine
New York, New York, United States, 10016
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44120-1013
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97201
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Memorial Hospital of Rhode Island (Brown University)
Pawtucket, Rhode Island, United States, 02860
United States, South Carolina
Medical University of South Carolina
North Charleston, South Carolina, United States, 29406
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9070
Sponsors and Collaborators
Investigators
Study Director: Steven H. Ferris, PhD New York University School of Medicine
  More Information

Additional Information:
Publications:
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.
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.
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.
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.
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.
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.
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.

Study ID Numbers: IA0032
Study First Received: April 30, 2002
Last Updated: September 14, 2007
ClinicalTrials.gov Identifier: NCT00034567     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Prevention

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on November 27, 2009