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Brain Exercises for Synaptic Plasticity

NCT ID: NCT03058055

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-15

Study Completion Date

2017-12-15

Brief Summary

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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

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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).

Conditions

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Cognitive Change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Placebo

Usual lifestyle activities

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BEHAVIORAL

The placebo group will have unstructured lifestyle activities (normal lifestyle activities without restraint).

Origami

Origami lessons (one hour/week) with daily take home Origami activities to complete

Group Type EXPERIMENTAL

Origami

Intervention Type BEHAVIORAL

Origami lessons (one hour/week) with daily take home Origami activities to complete

Reading

Daily reading (out loud into a voice recorder) for one hour

Group Type EXPERIMENTAL

Reading

Intervention Type BEHAVIORAL

Book club that includes weekly one hour meetings and daily reading assignments

Interventions

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Placebo

The placebo group will have unstructured lifestyle activities (normal lifestyle activities without restraint).

Intervention Type BEHAVIORAL

Origami

Origami lessons (one hour/week) with daily take home Origami activities to complete

Intervention Type BEHAVIORAL

Reading

Book club that includes weekly one hour meetings and daily reading assignments

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Non demented community dwelling elders

Exclusion Criteria

* Unable to perform the reading or origami tasks for any reason
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Kentucky

OTHER

Sponsor Role lead

Responsible Party

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Gregory Jicha, 323-5550

M.D., Ph.D., Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gregory A Jicha, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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Sander's Brown Center on Aging

Lexington, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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BEST

Identifier Type: -

Identifier Source: org_study_id