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Trial record 1 of 1 for:    NCT02943187
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Multidisciplinary Intervention for Mild Cognitive Impairment ((MCI))

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ClinicalTrials.gov Identifier: NCT02943187
Recruitment Status : Active, not recruiting
First Posted : October 24, 2016
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
True Life Medicine
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Cognitive training Dietary Supplement: Nutrition Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Functional Medicine Intervention With Cognitive Training for Mild Cognitive Impairment (MCI): A Multiple Baseline Study Across Cases
Study Start Date : October 2016
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: Nutrition and Cognitive Training
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
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.

Dietary Supplement: Nutrition
Participants will be given dietary recommendations and nutritional supplements to optimize cognition.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Evidence of improvement in executive function [ Time Frame: 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)

  2. Evidence of improvement in cognitive flexibility [ Time Frame: within 14 days after completing the intervention ]
    As confirmed by pretest to post-test changes on a Trail Making Test

  3. Evidence of change in brain function [ Time Frame: within 30 days after completing the intervention ]
    Confirmed by change in pretest to post-test neuroimaging using MRI

  4. Evidence of improvement in visual attention [ Time Frame: with 14 days after completing the intervention ]
    Confirmed by change in pretest to post-test scores on the Conners Continous Performance Test (CPT-3)

  5. Evidence of improvement in auditory attention [ Time Frame: with 14 days after completing the intervention ]
    Confirmed by change in pretest to post-test scores on the Auditory Attention Test (CATA)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943187


Locations
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United States, Colorado
Gibson Institute of Cognitive Research
Colorado Springs, Colorado, United States, 80919
Sponsors and Collaborators
Gibson Institute of Cognitive Research
True Life Medicine
Investigators
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Principal Investigator: Christina Ledbetter, PhD Gibson Institute of Cognitive Research
Study Director: Amy L Moore, PhD Gibson Institute of Cognitive Research
Principal Investigator: Randolph James, MD True Life Medicine
Principal Investigator: Dick M Carpenter, PhD University of Colorado, Colorado Springs
Additional Information:
Publications of Results:
James, R., Moore, A.L., Carpenter, D., Miller, T., & Ledbetter, C. (2019). Feasibility of a Functional Medicine Approach to Slowing Clinical Cognitive Decline in Patients Over Age 55: A Multiple Case Study Report. OBM Integrative and Complementary Medicine, 4(3). doi: 10.21926/obm.icm.1903054 Retrieved from https://www.lidsen.com/journals/icm/icm-04-03-054

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Responsible Party: Gibson Institute of Cognitive Research
ClinicalTrials.gov Identifier: NCT02943187    
Other Study ID Numbers: GICR-1012
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Harvard Dataverse
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders