HBA: Home-Based Assessment for Alzheimer Disease Prevention

• Sponsor: Alzheimer's Disease Cooperative Study (ADCS) (Other)
• Overall Status: Completed
• CT.gov ID: NCT00546767
• Collaborator: National Institute on Aging (NIA) (NIH)
• Enrollment: 640
• Locations: 28
• Arms: 4
• Duration (Months): 69
• Patients Per Site: 22.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment; Alzheimer's Disease	Behavioral: Mail and Live Phone; Behavioral: Interactive Voice Response (IVR); Behavioral: Home-based Computer Kiosk; Behavioral: Traditional Evaluation Instruments	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 640 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Multi-Center Trial to Evaluate Home-Based Assessment Methods for Alzheimer Disease Prevention Research in People Over 75 Years Old
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.
Active Comparator: Traditional	Behavioral: Traditional Evaluation Instruments; Evaluation methods typically used in clinical trials

Outcome Measures

Primary Outcome Measures

1. Feasibility Data -- the number of subjects recruited, screened, enrolled, and retained [4 years]

2. Efficiency Data -- staff time required to successfully complete data collection [Each experimental visit]

3. Transition from cognitive health to impairment [4 years]

4. Method-Specific Adherence, including medication adherence [4 years]

5. Rate of change in domains of assessment [4 years]

Secondary Outcome Measures

1. Research blood samples [4 years]

2. Safety Assessments: symptom checklist and adverse event checklist [4 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 75 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Alzheimer's Disease Cooperative Study (ADCS)
• National Institute on Aging (NIA)

Investigators

• Principal Investigator: Mary Sano, PhD, Mount Sinai Medical School

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Alzheimer's Disease Cooperative Study (ADCS)
• ClinicalTrials.gov Identifier: NCT00546767
• Other Study ID Numbers: IA0123; 1RC2AG036535; ADC-030-HBA
• First Posted: Oct 19, 2007
• Last Update Posted: Sep 16, 2014
• Last Verified: Sep 1, 2014

• Additional relevant MeSH terms: Alzheimer Disease; Cognitive Dysfunction

Study Results

No Results Posted as of Sep 16, 2014