Multidisciplinary Intervention for Mild Cognitive Impairment

Not Applicable

• Conditions: Mild Cognitive Impairment

• Registration Number: NCT02943187
• Lead Sponsor: Gibson Institute of Cognitive Research

Brief Summary

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

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).

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-21
• Study First Submitted QC: 2016-10-21
• Study First Posted: 2016-10-24
• Primary Completion: 2018-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gibson Institute of Cognitive Research; 🇺🇸 Colorado Springs, Colorado, United States