Effects of Memory Boot Camp on Brain Function in Adults With Symptoms of Mild Cognitive Impairment (MCI)

Study Overview
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Brief Summary
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This is a prospective controlled clinical trial to determine the effects of a 12-week Memory Boot Camp (MBC) program on cognitive function in older adults with symptoms of Mild Cognitive Impairment.

Detailed Description
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This prospective trial evaluates the 12-week, multi-domain Memory Boot Camp program for adults ages 55 to 85 with symptoms of mild cognitive impairment. The Memory Boot Camp program incorporates neurofeedback, heart rate variability biofeedback, memory and cognitive training, and one-on-one coaching to encourage behavior change in diet, sleep, physical fitness, and stress reduction. Participants are evaluated via neurocognitive assessments, questionnaires, quantitative electroencephalography parameters, and heart rate variability parameters at four time points: baseline, pre-program, post-program, and follow-up. The trial included a 12-week waiting period between baseline and pre-program, such that each participant acts as their own control, and follow-up takes place six months after completion of the program.

Official Title
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Effects of Memory Boot Camp on Brain Function in Adults With Symptoms of Mild Cognitive Impairment (MCI)

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Other: Multi-domain Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjective memory concerns At least a high school education Having a current primary care doctor (or agreement to get a primary care doctor) Ability to read and write English Time availability of 4-5 hours/week Be in good general health Exclusion Criteria: Major depression Known neurological illness (e.g. Alzheimer's or other dementia, Parkinson's, epilepsy, multiple sclerosis) Serious psychiatric diagnosis Substance abuse Complete blindness or deafness Plans to be out of town for more than 10 days during the active phase of the trial Current or past client of the Sponsor Complete blindness or deafness Employee or family member of Sponsor employee

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Memory Boot Camp Participants<br>All subjects undergo a 12-week control period, followed by a multi-domain 12-week memory program. | Other: Multi-domain Intervention<br>* Intervention includes neurofeedback, heart rate variability biofeedback, memory and cognitive training, and one-on-one coaching to encourage behavior change in diet, sleep, physical fitness, and stress reduction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Montreal Cognitive Assessment (MoCA) | The MoCA is a validated, brief assessment tool that measures MCI and is widely used. Individuals are scored on seven different domains: visuospatial/executive, naming, attention, language, abstraction, delayed recall, and orientation. | Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12). |