Home-Based Assessment for Alzheimer Disease Prevention
HBA
Multi-Center Trial to Evaluate Home-Based Assessment Methods for Alzheimer Disease Prevention Research in People Over 75 Years Old
3 other identifiers
interventional
640
1 country
28
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2007
Longer than P75 for not_applicable
28 active sites
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
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 11, 2007
CompletedFirst Posted
Study publicly available on registry
October 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedSeptember 16, 2014
September 1, 2014
5.8 years
October 11, 2007
September 15, 2014
Conditions
Outcome Measures
Primary Outcomes (5)
Feasibility Data -- the number of subjects recruited, screened, enrolled, and retained
4 years
Efficiency Data -- staff time required to successfully complete data collection
Each experimental visit
Transition from cognitive health to impairment
4 years
Method-Specific Adherence, including medication adherence
4 years
Rate of change in domains of assessment
4 years
Secondary Outcomes (2)
Research blood samples
4 years
Safety Assessments: symptom checklist and adverse event checklist
4 years
Study Arms (4)
Mail and Live Phone
EXPERIMENTALIVR
EXPERIMENTALComputer Kiosk
EXPERIMENTALTraditional
ACTIVE COMPARATORInterventions
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.
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.
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.
Evaluation methods typically used in clinical trials
Eligibility Criteria
You may qualify if:
- Age 75 and older
- 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
You may not qualify if:
- Dementia
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Sun Health Reseach Institute
Sun City, Arizona, 85351, United States
University of California, Irvine Institute for Brain Aging and Dementia
Irvine, California, 92697, United States
University of California-San Diego ADRC/Neurosciences
La Jolla, California, 92037, United States
University of California, Davis
Martinez, California, 94553, United States
Stanford University / PAIRE
Palo Alto, California, 94304, United States
Yale University Alzheimer's Disease Research Unit
New Haven, Connecticut, 06510, United States
Georgetown University
Washington D.C., District of Columbia, 20057, United States
Mayo Clinic Jacksonville Neurology
Jacksonville, Florida, 32224, United States
Wien Center
Miami Beach, Florida, 33140, United States
University of South Florida, Suncoast Alzheimer's & Gerontology Center
Tampa, Florida, 33617, United States
Northwestern University Cognitive Neurology & Alzheimer's Disease
Chicago, Illinois, 60611, United States
Rush Alzheimer's Disease Center
Chicago, Illinois, 60612, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Kentucky Sanders-Brown Center on Aging
Lexington, Kentucky, 40536, United States
Johns Hopkins University
Baltimore, Maryland, 21224, United States
Boston University Alzheimer's Disease Clinical and Research Program
Boston, Massachusetts, 02118, United States
University of Michigan Psychiatry - Neuropsychology
Ann Arbor, Michigan, 48105, United States
University of Nevada School of Medicine
Las Vegas, Nevada, 89102, United States
New York University Aging and Dementia Research Center
New York, New York, 10016, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Neurological Care of CNY
Syracuse, New York, 13210, United States
Wake Forest University Gerontology and Geriatric Medicine
Winston-Salem, North Carolina, 27157, United States
Case Western Reserve University
Cleveland, Ohio, 44120, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
University of Pennsylvania Geriatrics
Philadelphia, Pennsylvania, 19104, United States
University of Utah Center for Alzheimer's Care
Salt Lake City, Utah, 84108, United States
Related Publications (5)
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: 17135809BACKGROUNDMundt 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: 11700161BACKGROUNDPiette JD. Interactive voice response systems in the diagnosis and management of chronic disease. Am J Manag Care. 2000 Jul;6(7):817-27.
PMID: 11067378BACKGROUNDTornatore 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: 15746489BACKGROUNDWalsh 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: 17135810BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary Sano, PhD
Mount Sinai Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2007
First Posted
October 19, 2007
Study Start
September 1, 2007
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
September 16, 2014
Record last verified: 2014-09