Brain Exercises for Synaptic Plasticity: the BEST Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Kentucky
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- FCSRT
Study Overview
Brief Summary
The BEST study will investigate the feasibility of cognitive interventions in a randomized, placebo-controlled, clinical trial. The investigators will recruit 45 cognitively normal subjects and engage them in one of three cohorts over an 8 week period, including active reading vs. origami study arms and a placebo group without structured cognitive intervention.
Detailed Description
This is a randomized, placebo controlled study investigating the practical implementation and conduct of two cognitive interventions in non-demented subjects. Subjects will be randomized 1:1:1 into three groups including: 1) a Book club that includes weekly one hour meetings and daily reading assignments, 2) Origami lessons (one hour/week) with daily take home Origami activities to complete, and 3) a placebo group with unstructured lifestyle activities (normal lifestyle activities without restraint).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Non demented community dwelling elders
Exclusion Criteria
- •Unable to perform the reading or origami tasks for any reason
Arms & Interventions
Placebo
Usual lifestyle activities
Intervention: Placebo (Behavioral)
Origami
Origami lessons (one hour/week) with daily take home Origami activities to complete
Intervention: Origami (Behavioral)
Reading
Daily reading (out loud into a voice recorder) for one hour
Intervention: Reading (Behavioral)
Outcomes
Primary Outcomes
FCSRT
Time Frame: 8 weeks
The Free and Cued Selective Reminding Test (FCSRT) measures memory function.
MOCA
Time Frame: 8 weeks
The Montreal Cognitive Assessment (MOCA) measures general cognitive function
Secondary Outcomes
- Electroencephalogram(8 weeks)
- Evoked Related Potential(8 weeks)
- Adherence to protocol(8 weeks)
Investigators
Gregory Jicha, 323-5550
M.D., Ph.D., Professor
University of Kentucky