Mild Cognitive Impairment Clinical Trial
Official title:
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
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