Compensatory Training to Support Brain Healthy Lifestyle Changes in Those at Risk for Alzheimer's Disease

NCT ID: NCT04118985

Last Updated: 2020-11-17

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

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-10

Study Completion Date

2020-10-30

Brief Summary

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The Researchers are trying to better understand if behavioral interventions can help improve memory compensation and engagement in healthy lifestyle behaviors in those with memory concerns but normal mental status exam.

Detailed Description

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Conditions

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Cognitive Symptom Pre Senile Dementia Alzheimer Disease

Keywords

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Subjective cognitive complaint

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized to one of 1 arms: 1) provided recommendations and materials without coaching for implementation 2) provided recommendations and materials with 10 coaching classes
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Self-implementation

Individuals randomized to this group will be given all the materials about cognitive compensations techniques and brain health behavior guidelines and encouraged to implement those on their own.

Group Type ACTIVE_COMPARATOR

Self-implementation

Intervention Type BEHAVIORAL

Self-implementation of cognitive rehabilitation and health behavior change recommendations

Health-behavior intervention

Individuals randomized to this group will attend 10 weekly classes designed to provide information about cognitive compensation techniques and brain health behaviors as well as interventional support to implement those recommendations with homework and follow-up classes.

Group Type EXPERIMENTAL

Cognitive rehabilitation and health behavior change intervention

Intervention Type BEHAVIORAL

Cognitive rehabilitation and health behavior change intervention in a group-based program intervention compared to self-implementation of techniques without these interventions

Interventions

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Cognitive rehabilitation and health behavior change intervention

Cognitive rehabilitation and health behavior change intervention in a group-based program intervention compared to self-implementation of techniques without these interventions

Intervention Type BEHAVIORAL

Self-implementation

Self-implementation of cognitive rehabilitation and health behavior change recommendations

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 50 or older
* A positive complaint or concern in response to two questions ('Do you feel like your memory or other aspects of thinking are becoming worse?' and 'Does this worry you?')
* Normal cognitive performance on the Montreal Cognitive Assessment (adjusted for age and education)
* Self-reported independent function in daily life as measure by the Lawson IADL scale (IADL=8)
* English speaking
* Approval letter from a physician (due to the exercise component)

Exclusion Criteria

* Known neurological disorder with potential cognitive symptoms (a diagnosis of Parkinson's disease, epilepsy, a history of significant TBI, etc.)
* Uncontrolled moderate or severe depression (e.g., CES-D \> 21).
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Dona E. Locke

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dona Locke, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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19-006676

Identifier Type: -

Identifier Source: org_study_id