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Completed

NCT Number: NCT04118985

Compensatory Training to Support 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.

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Key information

Conditions

Cognitive Symptom Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pre Senile Dementia Signs and Symptoms Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Self-implementation

Behavioral

Self-implementation of cognitive rehabilitation and health behavior change recommendations

Primary outcomes

  1. Everyday Compensation Questionnaire

    Time frame: 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

  2. Lifestyle Activities Questionnaire

    Time frame: 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

  3. BrainHQ

    Time frame: 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

  4. Physical Activities Questionnaire

    Time frame: 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.

  5. Mindful Attention Awareness Scale

    Time frame: 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

Secondary outcomes

  1. Everyday Cognition

    Time frame: 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

  2. Quality of Life (in aging and cognitive health)

    Time frame: 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

  3. Psychological well-being

    Time frame: 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.

  4. Centers for Epidemiological Studies - Depression

    Time frame: 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

  5. Cognitive measure of memory

    Time frame: 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

  6. cognitive measure of executive functioning

    Time frame: 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

  7. cognitive measure of verbal fluency

    Time frame: 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

  8. cognitive measure of visual scanning speed

    Time frame: 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.

  9. cognitive measure of response inhibition

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2019
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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