Home-Based Assessment for Alzheimer Disease Prevention

Mild Cognitive Impairment Clinical Trial

— HBA  

Official title:

Multi-Center Trial to Evaluate Home-Based Assessment Methods for Alzheimer Disease Prevention Research in People Over 75 Years Old

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546767
• Other study ID #: IA0123
• Secondary ID: 1RC2AG036535ADC-
• Status: Completed
• Phase: N/A
• First received: October 11, 2007
• Last updated: September 15, 2014
• Start date: September 2007
• Est. completion date: June 2013

Study information

• Verified date: September 2014
• Source: Alzheimer's Disease Cooperative Study (ADCS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 75 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognition Disorders
• Mild Cognitive Impairment

Intervention

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.
• 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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Alzheimer's Disease Cooperative Study (ADCS)	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility Data -- the number of subjects recruited, screened, enrolled, and retained		4 years	No
Primary	Efficiency Data -- staff time required to successfully complete data collection		Each experimental visit	No
Primary	Transition from cognitive health to impairment		4 years	No
Primary	Method-Specific Adherence, including medication adherence		4 years	No
Primary	Rate of change in domains of assessment		4 years	No
Secondary	Research blood samples		4 years	No
Secondary	Safety Assessments: symptom checklist and adverse event checklist		4 years	Yes