Compensatory Training to Support Brain Healthy Lifestyle Changes in Those at Risk for Alzheimer's Disease
- Conditions
- Pre Senile DementiaCognitive SymptomAlzheimer Disease
- Interventions
- Behavioral: Cognitive rehabilitation and health behavior change interventionBehavioral: Self-implementation
- Registration Number
- NCT04118985
- Lead Sponsor
- Mayo Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Health-behavior intervention Cognitive rehabilitation and health behavior change 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. Self-implementation 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.
- Primary Outcome Measures
Name Time Method BrainHQ baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months Number of minutes on BrainHQ computer exercise program
Everyday Compensation Questionnaire baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months 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 baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months self-report of cognitive activities, range 13-65 with higher scores indicating more activity
Mindful Attention Awareness Scale baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months self-report of mindfulness, range of 11-66 with higher scores indicating more mindful daily experience
Physical Activities Questionnaire baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months 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.
- Secondary Outcome Measures
Name Time Method Quality of Life (in aging and cognitive health) baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months self-report of quality of life, range of 13-52 with higher scores indicating better quality of life
Psychological well-being baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months 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.
cognitive measure of executive functioning baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months 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 baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months 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
Everyday Cognition baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months self-report of everyday functioning, range 39-156 with higher scores indicating more problems in daily functioning
Centers for Epidemiological Studies - Depression baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months self-report of symptoms of depression.Range 0-60 with higher scores indicating more depression
Cognitive measure of memory baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months 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 response inhibition baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months 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
cognitive measure of visual scanning speed baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months 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.
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Scottsdale, Arizona, United States