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Clinical Trials/NCT02943187
NCT02943187
Unknown
Not Applicable

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

Gibson Institute of Cognitive Research1 site in 1 country5 target enrollmentOctober 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
Gibson Institute of Cognitive Research
Enrollment
5
Locations
1
Primary Endpoint
Evidence of overall cognitive function improvement
Last Updated
4 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
June 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Evidence of overall cognitive function improvement

Time Frame: within 14 days after completing the intervention

Confirmed by change in pretest to post-test scores on the Dementia Rating Scale (DRS-2)

Secondary Outcomes

  • Evidence of change in brain function(within 30 days after completing the intervention)
  • Evidence of improvement in executive function(within 14 days after completing the intervention)
  • Evidence of improvement in cognitive flexibility(within 14 days after completing the intervention)
  • Evidence of improvement in auditory attention(with 14 days after completing the intervention)
  • Evidence of improvement in visual attention(with 14 days after completing the intervention)

Study Sites (1)

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