Mild Cognitive Impairment Clinical Trial
Official title:
Developing a Multi-Domain Intervention to Maintain Cognitive Health in Sedentary Adults Ages 60 - 80
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
1. Design a multi-domain, lifestyle intervention to increase PA, social integration and
cognitive stimulation, and improve nutrition in sedentary, cognitively intact adults,
age 60 to 80.
2. Assess the feasibility of implementing such a multi-domain intervention:
1. recruit and screen 20 sedentary, cognitively intact adults aged 60 to 80 from a
health plan,
2. obtain baseline measures of cognitive function, physical and social activities,
mood, nutrition, height and weight, vascular risk factors of blood pressure and
fasting lipids, and biomarkers of inflammation,
3. engage these adults in a 4 month pilot of this multi-domain lifestyle intervention
with a phone coach and
4. obtain post-intervention measures of cognitive functioning, physical and social
activities, mood, nutrition, vascular risk factors of blood pressure and fasting
lipids, and biomarkers of inflammation.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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