Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-21 @ 9:56 PM
Study NCT ID:
NCT00546767
Status:
COMPLETED
Last Update Posted:
2014-09-16
First Post:
2007-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home-Based Assessment for Alzheimer Disease Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C417234', 'term': 'NFKBIZ protein, human'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 640}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-15', 'studyFirstSubmitDate': '2007-10-11', 'studyFirstSubmitQcDate': '2007-10-18', 'lastUpdatePostDateStruct': {'date': '2014-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility Data -- the number of subjects recruited, screened, enrolled, and retained', 'timeFrame': '4 years'}, {'measure': 'Efficiency Data -- staff time required to successfully complete data collection', 'timeFrame': 'Each experimental visit'}, {'measure': 'Transition from cognitive health to impairment', 'timeFrame': '4 years'}, {'measure': 'Method-Specific Adherence, including medication adherence', 'timeFrame': '4 years'}, {'measure': 'Rate of change in domains of assessment', 'timeFrame': '4 years'}], 'secondaryOutcomes': [{'measure': 'Research blood samples', 'timeFrame': '4 years'}, {'measure': 'Safety Assessments: symptom checklist and adverse event checklist', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment', "Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '17135809', 'type': 'BACKGROUND', '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': '11700161', 'type': 'BACKGROUND', 'citation': 'Mundt JC, Ferber KL, Rizzo M, Greist JH. Computer-automated dementia screening using a touch-tone telephone. Arch Intern Med. 2001 Nov 12;161(20):2481-7. doi: 10.1001/archinte.161.20.2481.'}, {'pmid': '11067378', 'type': 'BACKGROUND', 'citation': 'Piette JD. Interactive voice response systems in the diagnosis and management of chronic disease. Am J Manag Care. 2000 Jul;6(7):817-27.'}, {'pmid': '15746489', 'type': 'BACKGROUND', 'citation': 'Tornatore JB, Hill E, Laboff JA, McGann ME. Self-administered screening for mild cognitive impairment: initial validation of a computerized test battery. J Neuropsychiatry Clin Neurosci. 2005 Winter;17(1):98-105. doi: 10.1176/jnp.17.1.98.'}, {'pmid': '17135810', 'type': 'BACKGROUND', '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."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate three methods of performing home-based assessments in Alzheimer's Disease (AD) prevention trials. The initial in-person assessment will be done in the clinic or at home.", 'detailedDescription': 'There is an unmet need for effective, efficient, and economical methods for conducting AD prevention trials. Traditional in-person visits to clinical assessment sites are time consuming and costly and may exclude some people from participation, such as those who are older, or are less mobile or with significant medical illnesses. These may be the people who are at greatest risk for cognitive decline, and also may be without financial resources for services such as transportation to a study site. Prevention trials require long observation periods and these same issues of health, resources, and transportation may cause significant drop out. These obstacles increase expense of clinical trials which require large sample sizes, costly clinical staff and long observation periods. Thus, home-based assessments may lead to more representative recruitment of those most at risk for decline, as well as better retention and reduced study costs.\n\nThis is a randomized study of 600 participants, comparing three methods of test administration and data collection. Each enrolled participant will have an In-person (Standard) assessment (in the clinic or at home) prior to baseline.\n\nParticipants will be classified as either normal or MCI (Mild Cognitive Impairment) and randomly assigned to an assessment method and to a frequency of assessment. Cognitive performance, self-rated cognitive complaint, functioning in daily life, affective symptoms, global change, quality of life and resource use will all be assessed in each method at each visit. The total time for the at-home assessments will be approximately 45 minutes. In addition, all participants will be provided a multi-vitamin to be taken twice a day, and a measure of medication adherence will be collected for each assessment method.\n\nChanges in certain cognitive measures may "trigger" an in-person assessment, in which participants may change from a categorization of normal or amnestic MCI, to non-amnestic MCI, impaired not MCI, or dementia (i.e., specifically Alzheimer\'s Disease or another dementia). We estimate that 12% of the study population will trigger over the 4 years of the study and will progress to a more impaired diagnostic category. In addition, a random sample of non-triggered cases (25%) will be selected for an in-person re-assessment during the 4 years of the protocol as a comparison for the trigger group. At the end of the 4-year study period all participants will undergo an in-person evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 75 and older\n* Willing to sign consent\n* Willing to take multi-vitamins provided by the study\n* Minimal computer skills or willingness to learn (as demonstrated by completion during screening of a demonstration module for each arm)\n* English fluency\n* MMSE greater than 26\n* Able to answer and dial a telephone\n* Able to complete the in-person assessment\n* Able to complete the computerized assessment including adequate speech, hearing and vision\n* Independently living adults, defined as living in a setting in which the participant can ensure access to the resources for study procedures\n* Participation of a study partner is desirable and encouraged, but not required\n\nExclusion Criteria:\n\n* Dementia\n* Use of prescription cognitive-enhancing drugs at entry (e.g. Aricept, Razadyne, Exelon, Namenda)\n* Intent to continue use of own multi-vitamins (for the duration of the study participants must agree to take only study-distributed multi-vitamins)\n* History or presence of major psychiatric, neurological or neurodegenerative conditions associated with significant cognitive impairment such as major stroke, Parkinson's disease, Multiple Sclerosis or Huntington's disease. Transient Ischemic Attack (TIA) is acceptable if over 6 months ago\n* Medical conditions associated with life expectancy of less than 5 years\n* Transient domicile interfering with ability to collect study-related data\n* Current participation in a clinical trial involving Central Nervous System (CNS) medications or cognitive testing that would interfere with the current protocol (participation in Uniform Data Set (UDS) assessments by an ADC is permitted)\n* Cohabitation with another participant in this particular study"}, 'identificationModule': {'nctId': 'NCT00546767', 'acronym': 'HBA', 'briefTitle': 'Home-Based Assessment for Alzheimer Disease Prevention', 'organization': {'class': 'OTHER', 'fullName': "Alzheimer's Disease Cooperative Study (ADCS)"}, 'officialTitle': 'Multi-Center Trial to Evaluate Home-Based Assessment Methods for Alzheimer Disease Prevention Research in People Over 75 Years Old', 'orgStudyIdInfo': {'id': 'IA0123'}, 'secondaryIdInfos': [{'id': '1RC2AG036535', 'link': 'https://reporter.nih.gov/quickSearch/1RC2AG036535', 'type': 'NIH'}, {'id': 'ADC-030-HBA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mail and Live Phone', 'interventionNames': ['Behavioral: Mail and Live Phone']}, {'type': 'EXPERIMENTAL', 'label': 'IVR', 'interventionNames': ['Behavioral: Interactive Voice Response (IVR)']}, {'type': 'EXPERIMENTAL', 'label': 'Computer Kiosk', 'interventionNames': ['Behavioral: Home-based Computer Kiosk']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional', 'interventionNames': ['Behavioral: Traditional Evaluation Instruments']}], 'interventions': [{'name': 'Mail and Live Phone', 'type': 'BEHAVIORAL', 'description': 'This group will receive assessments of all domains by mail, except for the cognitive performance assessment which will be administered via phone by a live, trained evaluator. Medication compliance will be monitored by a written medication log which will be returned by mail with the other mail-in assessments.', 'armGroupLabels': ['Mail and Live Phone']}, {'name': 'Interactive Voice Response (IVR)', 'type': 'BEHAVIORAL', 'description': 'In this group, participants will be asked to answer questions via an automated phone system using interactive voice recognition (IVR) and key-pad response entry. Medication compliance will be monitored by the same method. A standard large-key telephone and training in the use of the interactive phone system will be provided to all participants.', 'armGroupLabels': ['IVR']}, {'name': 'Home-based Computer Kiosk', 'type': 'BEHAVIORAL', 'description': "Participants at entry will receive a special Kiosk-like device for collecting assessment information and will be taught to use this device. The user interface will consist of a monitor with a touch screen and a telephone handset, similar to what is often used in museum displays. Pre-recorded instructions will be delivered through the handset as well as displayed visually on the screen. Data will be collected using the handset's high-quality microphone. Daily activity assessments of timed medication use will be obtained via an automated medication tracking device.", 'armGroupLabels': ['Computer Kiosk']}, {'name': 'Traditional Evaluation Instruments', 'type': 'BEHAVIORAL', 'description': 'Evaluation methods typically used in clinical trials', 'armGroupLabels': ['Traditional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Sun Health Reseach Institute', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine Institute for Brain Aging and Dementia', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California-San Diego ADRC/Neurosciences', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94553', 'city': 'Martinez', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis', 'geoPoint': {'lat': 38.01937, 'lon': -122.13413}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University / PAIRE', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': "Yale University Alzheimer's Disease Research Unit", 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20057', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Jacksonville Neurology', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Wien Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '33617', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "University of South Florida, Suncoast Alzheimer's & Gerontology Center", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Northwestern University Cognitive Neurology & Alzheimer's Disease", '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', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Sanders-Brown Center on Aging', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston University Alzheimer's Disease Clinical and Research Program", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Psychiatry - Neuropsychology', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'University of Nevada School of Medicine', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Aging and Dementia Research Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Neurological Care of CNY', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Gerontology and Geriatric Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44120', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Geriatrics', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "University of Utah Center for Alzheimer's Care", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Mary Sano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Sinai Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Alzheimer's Disease Cooperative Study (ADCS)", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}