Back to resultsCompensatory Training to Support Brain Healthy Lifestyle Changes in Those at Risk for Alzheimer's Disease
Primary Purpose
Cognitive Symptom, Pre Senile Dementia, Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive rehabilitation and health behavior change intervention
Self-implementation
Sponsored by
About this trial
This is an interventional prevention trial for Cognitive Symptom focused on measuring Subjective cognitive complaint
Eligibility Criteria
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).
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Self-implementation
Health-behavior intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Everyday Compensation Questionnaire
self-report and informant report if an informant is available of compensatory strategy use; range 0-148 with higher scores indicating more compensatory use
Lifestyle Activities Questionnaire
self-report of cognitive activities, range 13-65 with higher scores indicating more activity
BrainHQ
Number of minutes on BrainHQ computer exercise program
Physical Activities Questionnaire
self-report of physical activity; scores include number of days per week across 7 activity types and number of minutes in each activity when completed.
Mindful Attention Awareness Scale
self-report of mindfulness, range of 11-66 with higher scores indicating more mindful daily experience
Secondary Outcome Measures
Everyday Cognition
self-report of everyday functioning, range 39-156 with higher scores indicating more problems in daily functioning
Quality of Life (in aging and cognitive health)
self-report of quality of life, range of 13-52 with higher scores indicating better quality of life
Psychological well-being
self-report of psychological well-being/happiness; there is a total score plus subscales of autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, self-acceptance. Each subscale has 9 items for a total of 54 items. Total scores range from 54-324 with higher scores indicating higher psychological well being. Each subscale ranges from 9-54 with higher scores indicating greater well-being on that construct.
Centers for Epidemiological Studies - Depression
self-report of symptoms of depression.Range 0-60 with higher scores indicating more depression
Cognitive measure of memory
Hopkins Verbal Memory test. Staff administered standardized verbal memory task. Scores include total words recalled and total recalled after a delay with higher scores indicating greater recall
cognitive measure of executive functioning
Trailmaking test; Staff administered standardized measure of attention and executive functioning. Scores include time to complete the task (with higher scores being slower) and number of errors
cognitive measure of verbal fluency
Controlled Oral Word Association Test; Staff administered standardized measure of speed and verbal fluency. Score is number of items in one minute with higher scores indicating better functioning
cognitive measure of visual scanning speed
Symbol Digit Modalities Test; Staff administered standardize measure of speed and visual scanning. Scores indicate number of items completed in the time frame with higher scores indicating better functioning.
cognitive measure of response inhibition
Stroop Color Word Test; Staff administered standardized measure of speed and response inhibition. Scores indicate number of items completed in the time limit with higher scores indicating better functioning
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04118985
Brief Title
Compensatory Training to Support Brain Healthy Lifestyle Changes in Those at Risk for Alzheimer's Disease
Official Title
Compensatory Training to Support Everyday Function and Adherence to Brain Healthy Lifestyle Changes in Those at Risk for Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Symptom, Pre Senile Dementia, Alzheimer Disease
Keywords
Subjective cognitive complaint
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized to one of 1 arms: 1) provided recommendations and materials without coaching for implementation 2) provided recommendations and materials with 10 coaching classes
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-implementation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Health-behavior intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive rehabilitation and health behavior change intervention
Intervention Description
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
Intervention Name(s)
Self-implementation
Intervention Description
Self-implementation of cognitive rehabilitation and health behavior change recommendations
Primary Outcome Measure Information:
Title
Everyday Compensation Questionnaire
Description
self-report and informant report if an informant is available of compensatory strategy use; range 0-148 with higher scores indicating more compensatory use
Time Frame
baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Title
Lifestyle Activities Questionnaire
Description
self-report of cognitive activities, range 13-65 with higher scores indicating more activity
Time Frame
baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Title
BrainHQ
Description
Number of minutes on BrainHQ computer exercise program
Time Frame
baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Title
Physical Activities Questionnaire
Description
self-report of physical activity; scores include number of days per week across 7 activity types and number of minutes in each activity when completed.
Time Frame
baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Title
Mindful Attention Awareness Scale
Description
self-report of mindfulness, range of 11-66 with higher scores indicating more mindful daily experience
Time Frame
baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Secondary Outcome Measure Information:
Title
Everyday Cognition
Description
self-report of everyday functioning, range 39-156 with higher scores indicating more problems in daily functioning
Time Frame
baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Title
Quality of Life (in aging and cognitive health)
Description
self-report of quality of life, range of 13-52 with higher scores indicating better quality of life
Time Frame
baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Title
Psychological well-being
Description
self-report of psychological well-being/happiness; there is a total score plus subscales of autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, self-acceptance. Each subscale has 9 items for a total of 54 items. Total scores range from 54-324 with higher scores indicating higher psychological well being. Each subscale ranges from 9-54 with higher scores indicating greater well-being on that construct.
Time Frame
baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Title
Centers for Epidemiological Studies - Depression
Description
self-report of symptoms of depression.Range 0-60 with higher scores indicating more depression
Time Frame
baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Title
Cognitive measure of memory
Description
Hopkins Verbal Memory test. Staff administered standardized verbal memory task. Scores include total words recalled and total recalled after a delay with higher scores indicating greater recall
Time Frame
baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Title
cognitive measure of executive functioning
Description
Trailmaking test; Staff administered standardized measure of attention and executive functioning. Scores include time to complete the task (with higher scores being slower) and number of errors
Time Frame
baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Title
cognitive measure of verbal fluency
Description
Controlled Oral Word Association Test; Staff administered standardized measure of speed and verbal fluency. Score is number of items in one minute with higher scores indicating better functioning
Time Frame
baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Title
cognitive measure of visual scanning speed
Description
Symbol Digit Modalities Test; Staff administered standardize measure of speed and visual scanning. Scores indicate number of items completed in the time frame with higher scores indicating better functioning.
Time Frame
baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Title
cognitive measure of response inhibition
Description
Stroop Color Word Test; Staff administered standardized measure of speed and response inhibition. Scores indicate number of items completed in the time limit with higher scores indicating better functioning
Time Frame
baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dona Locke, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The study is quite small and is meant a pilot data for preliminary feasibility and effect size estimating.
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Compensatory Training to Support Brain Healthy Lifestyle Changes in Those at Risk for Alzheimer's Disease
We'll reach out to this number within 24 hrs