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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04118985
• Other study ID #: 19-006676
• Status: Completed
• Phase: N/A
• Start date: October 10, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: November 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Symptom
• Dementia
• Neurobehavioral Manifestations
• Pre Senile Dementia

Intervention

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
• Self-implementation
Self-implementation of cognitive rehabilitation and health behavior change recommendations

Locations

Country	Name	City	State
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Mayo Clinic Clinical Trials