Clinical trial NCT00546767: Home-Based Assessment for Alzheimer Disease Prevention
Official title: Multi-Center Trial to Evaluate Home-Based Assessment Methods for Alzheimer Disease Prevention Research in People Over 75 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Alzheimer's Disease
Lead sponsor: Alzheimer's Disease Cooperative Study (ADCS)
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2007-10-19
Enrollment: 640
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility Data -- the number of subjects recruited, screened, enrolled, and retained
timeFrame: 4 years
measure: Efficiency Data -- staff time required to successfully complete data collection
timeFrame: Each experimental visit
measure: Transition from cognitive health to impairment
timeFrame: 4 years
measure: Method-Specific Adherence, including medication adherence
timeFrame: 4 years
measure: Rate of change in domains of assessment
timeFrame: 4 years
Secondary outcomes:
measure: Research blood samples
timeFrame: 4 years
measure: Safety Assessments: symptom checklist and adverse event checklist
timeFrame: 4 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Sun City
country: United States
facility: Sun Health Reseach Institute
state: Arizona
city: Irvine
country: United States
facility: University of California, Irvine Institute for Brain Aging and Dementia
state: California
city: La Jolla
country: United States
facility: University of California-San Diego ADRC/Neurosciences
state: California
city: Martinez
country: United States
facility: University of California, Davis
state: California
city: Palo Alto
country: United States
facility: Stanford University / PAIRE
state: California
city: New Haven
country: United States
facility: Yale University Alzheimer's Disease Research Unit
state: Connecticut
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville Neurology
state: Florida
city: Miami Beach
country: United States
facility: Wien Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida, Suncoast Alzheimer's & Gerontology Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University Cognitive Neurology & Alzheimer's Disease
state: Illinois
city: Chicago
country: United States
facility: Rush Alzheimer's Disease Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky Sanders-Brown Center on Aging
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Boston University Alzheimer's Disease Clinical and Research Program
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Psychiatry - Neuropsychology
state: Michigan
city: Las Vegas
country: United States
facility: University of Nevada School of Medicine
state: Nevada
city: New York
country: United States
facility: New York University Aging and Dementia Research Center
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Syracuse
country: United States
facility: Neurological Care of CNY
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Gerontology and Geriatric Medicine
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania Geriatrics
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah Center for Alzheimer's Care
state: Utah
Study officials:
affiliation: Mount Sinai Medical School
name: Mary Sano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1001/archinte.161.20.2481.
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.
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. doi: 10.1176/jnp.17.1.98.
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. doi: 10.1097/01.wad.0000213879.55547.57.