Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT00034567
Status:
COMPLETED
Last Update Posted:
2007-09-18
First Post:
2002-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Healthy Aging and Memory Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 650}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'lastUpdateSubmitDate': '2007-09-14', 'studyFirstSubmitDate': '2002-04-30', 'studyFirstSubmitQcDate': '2002-04-30', 'lastUpdatePostDateStruct': {'date': '2007-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-05-01', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Prevention'], 'conditions': ['Alzheimer Disease']}, 'referencesModule': {'references': [{'pmid': '17135805', 'type': 'RESULT', '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."}, {'pmid': '17135806', 'type': 'RESULT', '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."}, {'pmid': '17135809', 'type': 'RESULT', '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."}, {'pmid': '17135812', 'type': 'RESULT', '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.'}, {'pmid': '17135810', 'type': 'RESULT', '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."}, {'pmid': '17135808', 'type': 'RESULT', '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."}, {'pmid': '17135811', 'type': 'RESULT', '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."}], 'seeAlsoLinks': [{'url': 'http://adcs.ucsd.edu', 'label': "UCSD Alzheimer's Disease Cooperative Study"}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 75 years or older.\n* Fluent in English or Spanish.\n* Stable medical condition for four weeks prior to screening visit.\n* Stable medications for four weeks prior to screening visit.\n* Either cognitively normal, or mild cognitive impairment. If MCI, the subject's CDR at screening have a global score of 0.5.\n* 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.\n* Willing to participate in four to five year follow-up study.\n* Willing to identify person who can serve as informant.\n* At least six years education or work history sufficient to exclude mental retardation\n\nExclusion Criteria:\n\n* Meets DSM IV criteria for dementia\n* 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\n* Alcohol or substance abuse and/or active major psychiatric disorders\n* Concurrent participation in a clinical drug trial\n* History of mental retardation"}, 'identificationModule': {'nctId': 'NCT00034567', 'briefTitle': 'Healthy Aging and Memory Study', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Aging (NIA)'}, 'officialTitle': "Alzheimer's Disease Prevention Instrument Protocol", 'orgStudyIdInfo': {'id': 'IA0032'}}, 'contactsLocationsModule': {'locations': [{'zip': '35294-1150', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama, Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Sun Health Research Institute', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '92697-4285', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90033-1039', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095-1769', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford/Va Aging Clinical Research Center', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Baumel-Eisner Neuromedical Institute, Boca Raton', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33321', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Baumel-Eisner Ft Lauderdale', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic, Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Wien Center for Memory Disorders', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '33154', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Baumel-Eisner Neuromedical Institute, Miami Beach', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '33617', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida, Tampa', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Rush Alzheimer's Disease Center", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': "Indiana University Alzheimer's Center", 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40506', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky, Lexington', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21287-7218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University School of Medicine', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109-2007', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': "Michigan Alzheimer's Disease Research Center", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55901', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': "Mayo Alzheimer's Disease Center", 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'University of Nevada, Las Vegas', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt. Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '44120-1013', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97201', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02860', 'city': 'Pawtucket', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Memorial Hospital of Rhode Island (Brown University)', 'geoPoint': {'lat': 41.87871, 'lon': -71.38256}}, {'zip': '29406', 'city': 'North Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.85462, 'lon': -79.97481}}, {'zip': '75390-9070', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Steven H. Ferris, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}}}}