Clinical trial NCT04118985: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Symptom
Pre Senile Dementia
Alzheimer Disease
Keywords: Subjective cognitive complaint
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

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.


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).

Primary outcomes:
measure: Everyday Compensation Questionnaire
timeFrame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
measure: Lifestyle Activities Questionnaire
timeFrame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
measure: BrainHQ
timeFrame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
measure: Physical Activities Questionnaire
timeFrame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
measure: Mindful Attention Awareness Scale
timeFrame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Secondary outcomes:
measure: Everyday Cognition
timeFrame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
measure: Quality of Life (in aging and cognitive health)
timeFrame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
measure: Psychological well-being
timeFrame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
measure: Centers for Epidemiological Studies - Depression
timeFrame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
measure: Cognitive measure of memory
timeFrame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
measure: cognitive measure of executive functioning
timeFrame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
measure: cognitive measure of verbal fluency
timeFrame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
measure: cognitive measure of visual scanning speed
timeFrame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
measure: cognitive measure of response inhibition
timeFrame: baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Dona Locke, PhD
role: PRINCIPAL_INVESTIGATOR
References: