Mild Cognitive Impairment Clinical Trial
Official title:
A Multicenter Rehabilitation Intervention for Amnestic Mild Cognitive Impairment
Mild Cognitive Impairment (MCI) is often an early manifestation of Alzheimer's disease (AD).
The ability to identify MCI has led to hope that health prevention models might work in AD
as they have in cancer and heart disease. Interventions which help sustain functioning in
MCI may delay progression to a clinical AD diagnosis. To date, interventions aimed at
maintaining functioning in MCI have been pharmacologic in nature. The efficacy of these
medications in MCI is controversial, and those with MCI are also often interested in other
activities they can do to manage their memory loss.
When an individual is noted to have memory difficulties or MCI, a recommendation is often
given for the patient to begin taking notes/using a calendar to help with memory or do
cognitively stimulating activities. However, there is currently little instruction about
how/what specific activities one should do and how effective they may be. The overall goal
of this pilot project is to refine delivery of the Memory Support System (MSS)as a formal
compensatory program for memory loss in MCI. Enrollment and retention data will be carefully
investigated across 6 week and 10 day intervention groups. The investigators will compare
participant adherence to the notebook training in the 6 week and 10 day versions of the
intervention to the computer activity group. The investigators will also collect data on the
clinical efficacy of the notebook and computer training to investigate if these
interventions can sustain/improve functional level. Long term goals for this project also
include delaying relocation for persons with MCI who may progress to dementia, thus not only
improving the lives of these individuals, but also reducing health care expenditures.
The investigators will recruit a total of 60 individuals with MCI and their 60 program
partners across all three sites for this project. At least 16 of these pairs will be
recruited at Emory University (maximum of 20 pairs/40 individuals anticipated). The
investigators will randomly assign participants to the 6 week notebook or computer training
or 10 day notebook or computer training. All participants will also receive patient
education regarding MCI and cognitive health.
Subsequent compliance with the MSS will be examined at 3 months, 6 months, and then annually
following the intervention. Outcome measures will provide a detailed, multi-modal assessment
of participants' functional level, overall cognitive functioning, mood, and self-efficacy,
as well as caregiver burden and mood.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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