Multidisciplinary Intervention for Mild Cognitive Impairment

Study Overview
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Brief Summary
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The purpose of this investigation is to conduct a series of case studies on the impact of a novel functional medicine approach to improving cognitive skills, brain structure, and daily functioning for participants with Mild Cognitive Impairment (MCI).

Detailed Description
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Using a multiple baseline design across cases with start point randomization, the proposed study will examine the outcomes from a combination of optimized diet, exercise, nutritional supplements, and cognitive training across domains on standardized measures used to monitor treatment effectiveness for Mild Cognitive Impairment (MCI).

Official Title
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Novel Functional Medicine Intervention With Cognitive Training for Mild Cognitive Impairment (MCI): A Multiple Baseline Study Across Cases

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Cognitive training
* Dietary Supplement: Nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50+ previously diagnosed with MCI Living in the greater Colorado Springs area Exclusion Criteria: No braces, metal implants, or claustrophobia that would contraindicate magnetic resonance imaging

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Nutrition and Cognitive Training<br>The intervention includes a physician-directed diet, exercise, and nutritional supplementation regimen, combined with a 60-hour, clinician-delivered cognitive training program created by LearningRx. | Behavioral: Cognitive training<br>* A clinician will deliver three 90-minute cognitive training sessions per week for 14 weeks. There are 16 different categories of leveled training procedures sequenced in intensity and difficulty for a total of 530 training tasks.<br>Dietary Supplement: Nutrition<br>* Participants will be given dietary recommendations and nutritional supplements to optimize cognition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of overall cognitive function improvement | Confirmed by change in pretest to post-test scores on the Dementia Rating Scale (DRS-2) | within 14 days after completing the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of improvement in executive function | As confirmed by pretest to post-test changes on the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) | within 14 days after completing the intervention | 
| Evidence of improvement in cognitive flexibility | As confirmed by pretest to post-test changes on a Trail Making Test | within 14 days after completing the intervention | 
| Evidence of change in brain function | Confirmed by change in pretest to post-test neuroimaging using MRI | within 30 days after completing the intervention | 
| Evidence of improvement in visual attention | Confirmed by change in pretest to post-test scores on the Conners Continous Performance Test (CPT-3) | with 14 days after completing the intervention | 
| Evidence of improvement in auditory attention | Confirmed by change in pretest to post-test scores on the Auditory Attention Test (CATA) | with 14 days after completing the intervention |