NCT03058055

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

1.4 years

First QC Date

February 12, 2017

Last Update Submit

December 17, 2017

Conditions

Cognitive Change

Outcome Measures

Primary Outcomes (2)

  • MOCA

    The Montreal Cognitive Assessment (MOCA) measures general cognitive function

    8 weeks

  • FCSRT

    The Free and Cued Selective Reminding Test (FCSRT) measures memory function.

    8 weeks

Secondary Outcomes (3)

  • Adherence to protocol

    8 weeks

  • Electroencephalogram

    8 weeks

  • Evoked Related Potential

    8 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Usual lifestyle activities

Behavioral: Placebo

Origami

EXPERIMENTAL

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

Behavioral: Origami

Reading

EXPERIMENTAL

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

Behavioral: Reading

Interventions

PlaceboBEHAVIORAL

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

Placebo
OrigamiBEHAVIORAL

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

Origami
ReadingBEHAVIORAL

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

Reading

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Non demented community dwelling elders

You may not qualify if:

  • Unable to perform the reading or origami tasks for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sander's Brown Center on Aging

Lexington, Kentucky, 40536, United States

Location

Study Officials

  • Gregory A Jicha, MD, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D., Professor

Study Record Dates

First Submitted

February 12, 2017

First Posted

February 20, 2017

Study Start

July 15, 2016

Primary Completion

December 15, 2017

Study Completion

December 15, 2017

Last Updated

December 19, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)