Healthy Aging and Memory Study

NCT ID: NCT00034567

Last Updated: 2007-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

650 participants

Study Classification

OBSERVATIONAL

Brief Summary

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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

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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.

Conditions

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Alzheimer Disease

Keywords

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Prevention

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role lead

Principal Investigators

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Steven H. Ferris, PhD

Role: STUDY_DIRECTOR

NYU Langone Health

Locations

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University of Alabama, Birmingham

Birmingham, Alabama, United States

Site Status

Sun Health Research Institute

Sun City, Arizona, United States

Site Status

University of California, Irvine

Irvine, California, United States

Site Status

University of California, San Diego

La Jolla, California, United States

Site Status

University of Southern California

Los Angeles, California, United States

Site Status

University of California, Los Angeles

Los Angeles, California, United States

Site Status

Stanford/Va Aging Clinical Research Center

Palo Alto, California, United States

Site Status

University of California, Davis

Sacramento, California, United States

Site Status

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

Baumel-Eisner Neuromedical Institute, Boca Raton

Boca Raton, Florida, United States

Site Status

Baumel-Eisner Ft Lauderdale

Fort Lauderdale, Florida, United States

Site Status

Mayo Clinic, Jacksonville

Jacksonville, Florida, United States

Site Status

Wien Center for Memory Disorders

Miami Beach, Florida, United States

Site Status

Baumel-Eisner Neuromedical Institute, Miami Beach

Miami Beach, Florida, United States

Site Status

University of South Florida, Tampa

Tampa, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Rush Alzheimer's Disease Center

Chicago, Illinois, United States

Site Status

Indiana University Alzheimer's Center

Indianapolis, Indiana, United States

Site Status

University of Kentucky, Lexington

Lexington, Kentucky, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Boston University School of Medicine

Boston, Massachusetts, United States

Site Status

Michigan Alzheimer's Disease Research Center

Ann Arbor, Michigan, United States

Site Status

Mayo Alzheimer's Disease Center

Rochester, Minnesota, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

University of Nevada, Las Vegas

Las Vegas, Nevada, United States

Site Status

New York University School of Medicine

New York, New York, United States

Site Status

Mt. Sinai Medical Center

New York, New York, United States

Site Status

Columbia University

New York, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

University Hospitals of Cleveland

Cleveland, Ohio, United States

Site Status

Oregon Health Sciences University

Portland, Oregon, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Memorial Hospital of Rhode Island (Brown University)

Pawtucket, Rhode Island, United States

Site Status

Medical University of South Carolina

North Charleston, South Carolina, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 17135805 (View on PubMed)

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.

Reference Type RESULT
PMID: 17135806 (View on PubMed)

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.

Reference Type RESULT
PMID: 17135809 (View on PubMed)

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.

Reference Type RESULT
PMID: 17135812 (View on PubMed)

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.

Reference Type RESULT
PMID: 17135810 (View on PubMed)

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.

Reference Type RESULT
PMID: 17135808 (View on PubMed)

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.

Reference Type RESULT
PMID: 17135811 (View on PubMed)

Related Links

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http://adcs.ucsd.edu

UCSD Alzheimer's Disease Cooperative Study

Other Identifiers

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IA0032

Identifier Type: -

Identifier Source: org_study_id