Study Results
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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COMPLETED
NA
640 participants
INTERVENTIONAL
2007-09-30
2013-06-30
Brief Summary
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Detailed Description
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This 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.
Participants 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.
Changes 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Mail and Live Phone
Mail and Live Phone
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.
IVR
Interactive Voice Response (IVR)
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.
Computer Kiosk
Home-based Computer Kiosk
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.
Traditional
Traditional Evaluation Instruments
Evaluation methods typically used in clinical trials
Interventions
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Mail and Live Phone
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.
Interactive Voice Response (IVR)
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.
Home-based Computer Kiosk
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.
Traditional Evaluation Instruments
Evaluation methods typically used in clinical trials
Eligibility Criteria
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Inclusion Criteria
* Willing to sign consent
* Willing to take multi-vitamins provided by the study
* Minimal computer skills or willingness to learn (as demonstrated by completion during screening of a demonstration module for each arm)
* English fluency
* MMSE greater than 26
* Able to answer and dial a telephone
* Able to complete the in-person assessment
* Able to complete the computerized assessment including adequate speech, hearing and vision
* Independently living adults, defined as living in a setting in which the participant can ensure access to the resources for study procedures
* Participation of a study partner is desirable and encouraged, but not required
Exclusion Criteria
* Use of prescription cognitive-enhancing drugs at entry (e.g. Aricept, Razadyne, Exelon, Namenda)
* Intent to continue use of own multi-vitamins (for the duration of the study participants must agree to take only study-distributed multi-vitamins)
* 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
* Medical conditions associated with life expectancy of less than 5 years
* Transient domicile interfering with ability to collect study-related data
* 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)
* Cohabitation with another participant in this particular study
75 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Alzheimer's Disease Cooperative Study (ADCS)
OTHER
Responsible Party
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Principal Investigators
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Mary Sano, PhD
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai Medical School
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Sun Health Reseach Institute
Sun City, Arizona, United States
University of California, Irvine Institute for Brain Aging and Dementia
Irvine, California, United States
University of California-San Diego ADRC/Neurosciences
La Jolla, California, United States
University of California, Davis
Martinez, California, United States
Stanford University / PAIRE
Palo Alto, California, United States
Yale University Alzheimer's Disease Research Unit
New Haven, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
Mayo Clinic Jacksonville Neurology
Jacksonville, Florida, United States
Wien Center
Miami Beach, Florida, United States
University of South Florida, Suncoast Alzheimer's & Gerontology Center
Tampa, Florida, United States
Northwestern University Cognitive Neurology & Alzheimer's Disease
Chicago, Illinois, United States
Rush Alzheimer's Disease Center
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Kentucky Sanders-Brown Center on Aging
Lexington, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston University Alzheimer's Disease Clinical and Research Program
Boston, Massachusetts, United States
University of Michigan Psychiatry - Neuropsychology
Ann Arbor, Michigan, United States
University of Nevada School of Medicine
Las Vegas, Nevada, United States
New York University Aging and Dementia Research Center
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Neurological Care of CNY
Syracuse, New York, United States
Wake Forest University Gerontology and Geriatric Medicine
Winston-Salem, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania Geriatrics
Philadelphia, Pennsylvania, United States
University of Utah Center for Alzheimer's Care
Salt Lake City, Utah, United States
Countries
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References
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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.
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.
Piette JD. Interactive voice response systems in the diagnosis and management of chronic disease. Am J Manag Care. 2000 Jul;6(7):817-27.
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.
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.
Other Identifiers
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ADC-030-HBA
Identifier Type: -
Identifier Source: secondary_id
IA0123
Identifier Type: -
Identifier Source: org_study_id
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