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

NCT04118985 | Completed

• 1 other identifier: 19-006676
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Symptom; Pre Senile Dementia; Alzheimer Disease

Keywords

Subjective cognitive complaint

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (9)

• Everyday Cognition

  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)

  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

  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

  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

  baseline, change from baseline at end of 10 week treatment, change from baseline at 3 months, change from baseline at 6 months

Study Arms (2)

Self-implementation

ACTIVE COMPARATOR

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

Health-behavior intervention

EXPERIMENTAL

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

Interventions

Cognitive rehabilitation and health behavior change intervention BEHAVIORAL

Cognitive rehabilitation and health behavior change intervention in a group-based program intervention compared to self-implementation of techniques without these interventions

Health-behavior intervention

Self-implementation BEHAVIORAL

Self-implementation of cognitive rehabilitation and health behavior change recommendations

Self-implementation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Neurobehavioral Manifestations; Alzheimer Disease

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Dona Locke, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized to one of 1 arms: 1) provided recommendations and materials without coaching for implementation 2) provided recommendations and materials with 10 coaching classes

Study Record Dates

• First Submitted: September 8, 2019
• First Posted: October 8, 2019
• Study Start: October 10, 2019
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)