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

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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Cognitive Symptom; Pre Senile Dementia
• Intervention / Treatment: Behavioral: Self-implementation; Behavioral: Cognitive rehabilitation and health behavior change intervention

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Self-implementation; Self-implementation of cognitive rehabilitation and health behavior change recommendations
Experimental: 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.	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Lifestyle Activities Questionnaire	self-report of cognitive activities, range 13-65 with higher scores indicating more activity	baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
BrainHQ	Number of minutes on BrainHQ computer exercise program	baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
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.	baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Mindful Attention Awareness Scale	self-report of mindfulness, range of 11-66 with higher scores indicating more mindful daily experience	baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Everyday Cognition	self-report of everyday functioning, range 39-156 with higher scores indicating more problems in daily functioning	baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
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	baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
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.	baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Centers for Epidemiological Studies - Depression	self-report of symptoms of depression.Range 0-60 with higher scores indicating more depression	baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
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	baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
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	baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
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	baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
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.	baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
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	baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Dona Locke, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2019
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: September 8, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 15, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Subjective cognitive complaint
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease; Neurobehavioral Manifestations
• Other Study ID Numbers: 19-006676

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study is quite small and is meant a pilot data for preliminary feasibility and effect size estimating.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No