Alzheimer's Disease, Mild Cognitive Impairment
Conditions
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.
Interventions
BEHAVIORALMail 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.
BEHAVIORALInteractive 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.
BEHAVIORALHome-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.
BEHAVIORALTraditional Evaluation Instruments
Evaluation methods typically used in clinical trials
Sponsors
National Institute on Aging (NIA)
Alzheimer's Disease Cooperative Study (ADCS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficiency Data -- staff time required to successfully complete data collection | Each experimental visit |
| Method-Specific Adherence, including medication adherence | 4 years |
| Rate of change in domains of assessment | 4 years |
| Feasibility Data -- the number of subjects recruited, screened, enrolled, and retained | 4 years |
| Transition from cognitive health to impairment | 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Safety Assessments: symptom checklist and adverse event checklist | 4 years |
| Research blood samples | 4 years |
Countries
United States
Outcome results
None listed