An interventional study of Guided and Self-directed in Mild Cognitive Impairment and Alzheimer's Disease, sponsored by HealthPartners Institute. Completed at 1 site in United States. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-09-18.
Sponsored by HealthPartners Institute · Not applicable, Interventional, and Prevention
Numerous modifiable lifestyle factors have been identified that may affect the risk of older adults developing mild cognitive impairment (MCI) and Alzheimer's disease (AD). Evidence suggests that interventions to reduce risk factors and enhance protective factors would be beneficial in slowing cognitive decline and decreasing the risk of incident MCI and AD. The overall objective of this pilot study, funded as a supplement to Keep Active Minnesota (KAM) (03-024; R01-AG023410) is to develop and test the feasibility of conducting a multi-domain intervention to maintain cognitive health in adults ages 60-80 with the goal of reducing the incidence of and slowing progression to MCI and other more severe forms of cognitive decline.
The initial aim of the project was to recruit 20 cognitively intact adults ages 60-80 from one health plan, assessing them at baseline with respect to their cognitive health, multiple lifestyle factors, biomarkers and biometrics, engaging them in a 12 week lifestyle intervention and re-assessing them immediately post-intervention.
Specific Aims
Assess the feasibility of implementing such a multi-domain intervention:
After successfully recruiting the first 20 subjects, we determined that the grant budget would allow us to enrich the study by recruiting 40 more subjects. A second, comparison arm was added. The first study arm received the intervention as described above. Subjects assigned (by chance) to the comparison arm received study materials but did not have a phone coach assigned. The additional 40 subjects were genotyped with respect to the apolipoprotein E4 (apoE4) allele.
This feasibility pilot of an evidence-based intervention targets protective lifestyle factors related to cognitive health, including physical and social activities, cognitive stimulation and nutrition. The information gained on intervention design, implementation, and subject recruitment, will guide development of a full-scale intervention study of primary prevention of cognitive decline.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 63 is close to the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →HealthPartners Institute is the lead sponsor of 164 studies on the registry; 20 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 16 (94%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Guided
Behavioral: Self-directed
Engaged in a 4 month pilot of a multi-domain lifestyle intervention with a phone coach
Received study materials but no phone coaching
We will use this pilot to determine the feasibility of carrying out a full-scale randomized trial to test the efficacy of our intervention.
Time frame: Six months after the baseline visit
This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.
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HealthPartners Institute