NCT00034567

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

39 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2002

Completed
Last Updated

September 18, 2007

Status Verified

September 1, 2007

First QC Date

April 30, 2002

Last Update Submit

September 14, 2007

Conditions

Keywords

Prevention

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (39)

University of Alabama, Birmingham

Birmingham, Alabama, 35294-1150, United States

Location

Sun Health Research Institute

Sun City, Arizona, 85351, United States

Location

University of California, Irvine

Irvine, California, 92697-4285, United States

Location

University of California, San Diego

La Jolla, California, 92037, United States

Location

University of Southern California

Los Angeles, California, 90033-1039, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095-1769, United States

Location

Stanford/Va Aging Clinical Research Center

Palo Alto, California, 94304, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Baumel-Eisner Neuromedical Institute, Boca Raton

Boca Raton, Florida, 33486, United States

Location

Baumel-Eisner Ft Lauderdale

Fort Lauderdale, Florida, 33321, United States

Location

Mayo Clinic, Jacksonville

Jacksonville, Florida, 32224, United States

Location

Wien Center for Memory Disorders

Miami Beach, Florida, 33140, United States

Location

Baumel-Eisner Neuromedical Institute, Miami Beach

Miami Beach, Florida, 33154, United States

Location

University of South Florida, Tampa

Tampa, Florida, 33617, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush Alzheimer's Disease Center

Chicago, Illinois, 60612, United States

Location

Indiana University Alzheimer's Center

Indianapolis, Indiana, 46202, United States

Location

University of Kentucky, Lexington

Lexington, Kentucky, 40506, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287-7218, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Michigan Alzheimer's Disease Research Center

Ann Arbor, Michigan, 48109-2007, United States

Location

Mayo Alzheimer's Disease Center

Rochester, Minnesota, 55901, United States

Location

Washington University

St Louis, Missouri, 63108, United States

Location

University of Nevada, Las Vegas

Las Vegas, Nevada, 89102, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

Mt. Sinai Medical Center

New York, New York, 10029, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Rochester

Rochester, New York, 14620, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44120-1013, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97201, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Memorial Hospital of Rhode Island (Brown University)

Pawtucket, Rhode Island, 02860, United States

Location

Medical University of South Carolina

North Charleston, South Carolina, 29406, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9070, United States

Location

Related Publications (7)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Steven H. Ferris, PhD

    NYU Langone Health

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

April 30, 2002

First Posted

May 1, 2002

Last Updated

September 18, 2007

Record last verified: 2007-09

Locations