Alzheimer DiseaseNCT00034567
Healthy Aging and Memory Study
An observational study of Alzheimer Disease, run by National Institute on Aging (NIA) at 39 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- How many people
- 650 participants
- Where
- 39 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Michigan Alzheimer's Disease Research Center
Ann Arbor, Michigan, 48109-2007
Emory University
Atlanta, Georgia, 30329
Johns Hopkins University
Baltimore, Maryland, 21287-7218
University of Alabama, Birmingham
Birmingham, Alabama, 35294-1150
Baumel-Eisner Neuromedical Institute, Boca Raton
Boca Raton, Florida, 33486
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boston University School of Medicine
Boston, Massachusetts, 02118
Northwestern University
Chicago, Illinois, 60611
Rush Alzheimer's Disease Center
Chicago, Illinois, 60612
University Hospitals of Cleveland
Cleveland, Ohio, 44120-1013
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9070
Baumel-Eisner Ft Lauderdale
Fort Lauderdale, Florida, 33321
Indiana University Alzheimer's Center
Indianapolis, Indiana, 46202
University of California, Irvine
Irvine, California, 92697-4285
Mayo Clinic, Jacksonville
Jacksonville, Florida, 32224
University of California, San Diego
La Jolla, California, 92037
University of Nevada, Las Vegas
Las Vegas, Nevada, 89102
University of Kentucky, Lexington
Lexington, Kentucky, 40506
University of Southern California
Los Angeles, California, 90033-1039
University of California, Los Angeles
Los Angeles, California, 90095-1769
Wien Center for Memory Disorders
Miami Beach, Florida, 33140
Baumel-Eisner Neuromedical Institute, Miami Beach
Miami Beach, Florida, 33154
Yale University School of Medicine
New Haven, Connecticut, 06510
New York University School of Medicine
New York, New York, 10016
Mt. Sinai Medical Center
New York, New York, 10029
Columbia University
New York, New York, 10032
Medical University of South Carolina
North Charleston, South Carolina, 29406
Stanford/Va Aging Clinical Research Center
Palo Alto, California, 94304
Memorial Hospital of Rhode Island (Brown University)
Pawtucket, Rhode Island, 02860
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Oregon Health Sciences University
Portland, Oregon, 97201
Mayo Alzheimer's Disease Center
Rochester, Minnesota, 55901
University of Rochester
Rochester, New York, 14620
University of California, Davis
Sacramento, California, 95817
Washington University
St Louis, Missouri, 63108
Sun Health Research Institute
Sun City, Arizona, 85351
University of South Florida, Tampa
Tampa, Florida, 33617
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: Alzheimer's Disease Prevention Instrument Protocol
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Keywords
- Prevention
- Medical subject headings
- Alzheimer Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 650 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Steven H. Ferris, PhD, Study director, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034567
- Sponsor's protocol ID
- IA0032
- Status last verified
- Sep 2007
- First submitted
- 30 Apr 2002
- Last updated
- 18 Sep 2007
- Results posted
- No
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. doi: 10.1097/01.wad.0000213870.40300.21.
PubMed 17135805Schneider 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.
PubMed 17135806Galasko 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.
PubMed 17135809Sano 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.
PubMed 17135812Walsh 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.
PubMed 17135810Cummings 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.
PubMed 17135808Patterson 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.
PubMed 17135811
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alzheimer's Disease Prevention Instrument Protocol
- ClinicalTrials.gov ID
- NCT00034567
- Acronym / sponsor ID
- IA0032
- Conditions
- Alzheimer Disease
- Keywords
- Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 650 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- First posted
- 1 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2007.
- Results publication: PubMed 17135805Ferris 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.
- Results publication: PubMed 17135806Schneider 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.
- Results publication: PubMed 17135809Galasko 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.
- Results publication: PubMed 17135812Sano 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.
- Results publication: PubMed 17135810Walsh 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.
- Results publication: PubMed 17135808Cummings 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.
- Results publication: PubMed 17135811Patterson 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.
- UCSD Alzheimer's Disease Cooperative StudyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven H. Ferris, PhD study director
NYU Langone Health
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by National Institute on Aging (NIA) at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00034567, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2007.