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

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment; Alzheimer's Disease
• Intervention / Treatment: Behavioral: Mail and Live Phone; Behavioral: Interactive Voice Response (IVR); Behavioral: Home-based Computer Kiosk; Behavioral: Traditional Evaluation Instruments

Detailed Description

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.

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.

• Study Type: Interventional
• Enrollment (Actual): 640
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Arizona
    • Sun City, Arizona, United States, 85351
      • Sun Health Reseach Institute
  • California
    • Irvine, California, United States, 92697
      • University of California, Irvine Institute for Brain Aging and Dementia
    • La Jolla, California, United States, 92037
      • University of California-San Diego ADRC/Neurosciences
    • Martinez, California, United States, 94553
      • University of California, Davis
    • Palo Alto, California, United States, 94304
      • Stanford University / PAIRE
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University Alzheimer's Disease Research Unit
  • District of Columbia
    • Washington, District of Columbia, United States, 20057
      • Georgetown University
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville Neurology
    • Miami Beach, Florida, United States, 33140
      • Wien Center
    • Tampa, Florida, United States, 33617
      • University of South Florida, Suncoast Alzheimer's & Gerontology Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush Alzheimer's Disease Center
    • Chicago, Illinois, United States, 60611
      • Northwestern University Cognitive Neurology & Alzheimer's Disease
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Sanders-Brown Center on Aging
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University Alzheimer's Disease Clinical and Research Program
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • University of Michigan Psychiatry - Neuropsychology
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • University of Nevada School of Medicine
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
    • New York, New York, United States, 10016
      • New York University Aging and Dementia Research Center
    • Syracuse, New York, United States, 13210
      • Neurological Care of CNY
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Gerontology and Geriatric Medicine
  • Ohio
    • Cleveland, Ohio, United States, 44120
      • Case Western Reserve University
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Geriatrics
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah Center for Alzheimer's Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional	Behavioral: Traditional Evaluation Instruments; Evaluation methods typically used in clinical trials
Experimental: Mail and Live Phone	Behavioral: 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.
Experimental: IVR	Behavioral: 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.
Experimental: Computer Kiosk	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Research blood samples	4 years
Safety Assessments: symptom checklist and adverse event checklist	4 years

Collaborators and Investigators

• Sponsor: Alzheimer's Disease Cooperative Study (ADCS)
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Mary Sano, PhD, Mount Sinai Medical School

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: October 11, 2007
• First Submitted That Met QC Criteria: October 18, 2007
• First Posted (Estimate): October 19, 2007

Study Record Updates

• Last Update Posted (Estimate): September 16, 2014
• Last Update Submitted That Met QC Criteria: September 15, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: IA0123; 1RC2AG036535 (U.S. NIH Grant/Contract); ADC-030-HBA