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Multidisciplinary Intervention for Mild Cognitive Impairment ((MCI))

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive training
Nutrition
Sponsored by
Gibson Institute of Cognitive Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Gibson Institute of Cognitive Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nutrition and Cognitive Training

Arm Description

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.

Outcomes

Primary Outcome Measures

Evidence of overall cognitive function improvement
Confirmed by change in pretest to post-test scores on the Dementia Rating Scale (DRS-2)

Secondary Outcome Measures

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)
Evidence of improvement in cognitive flexibility
As confirmed by pretest to post-test changes on a Trail Making Test
Evidence of change in brain function
Confirmed by change in pretest to post-test neuroimaging using MRI
Evidence of improvement in visual attention
Confirmed by change in pretest to post-test scores on the Conners Continous Performance Test (CPT-3)
Evidence of improvement in auditory attention
Confirmed by change in pretest to post-test scores on the Auditory Attention Test (CATA)

Full Information

First Posted
October 21, 2016
Last Updated
July 26, 2021
Sponsor
Gibson Institute of Cognitive Research
Collaborators
True Life Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02943187
Brief Title
Multidisciplinary Intervention for Mild Cognitive Impairment
Acronym
(MCI)
Official Title
Novel Functional Medicine Intervention With Cognitive Training for Mild Cognitive Impairment (MCI): A Multiple Baseline Study Across Cases
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gibson Institute of Cognitive Research
Collaborators
True Life Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrition and Cognitive Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrition
Intervention Description
Participants will be given dietary recommendations and nutritional supplements to optimize cognition.
Primary Outcome Measure Information:
Title
Evidence of overall cognitive function improvement
Description
Confirmed by change in pretest to post-test scores on the Dementia Rating Scale (DRS-2)
Time Frame
within 14 days after completing the intervention
Secondary Outcome Measure Information:
Title
Evidence of improvement in executive function
Description
As confirmed by pretest to post-test changes on the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
Time Frame
within 14 days after completing the intervention
Title
Evidence of improvement in cognitive flexibility
Description
As confirmed by pretest to post-test changes on a Trail Making Test
Time Frame
within 14 days after completing the intervention
Title
Evidence of change in brain function
Description
Confirmed by change in pretest to post-test neuroimaging using MRI
Time Frame
within 30 days after completing the intervention
Title
Evidence of improvement in visual attention
Description
Confirmed by change in pretest to post-test scores on the Conners Continous Performance Test (CPT-3)
Time Frame
with 14 days after completing the intervention
Title
Evidence of improvement in auditory attention
Description
Confirmed by change in pretest to post-test scores on the Auditory Attention Test (CATA)
Time Frame
with 14 days after completing the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Ledbetter, PhD
Organizational Affiliation
Gibson Institute of Cognitive Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amy L Moore, PhD
Organizational Affiliation
Gibson Institute of Cognitive Research
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Randolph James, MD
Organizational Affiliation
True Life Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dick M Carpenter, PhD
Organizational Affiliation
University of Colorado, Colorado Springs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gibson Institute of Cognitive Research
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80919
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Harvard Dataverse
Citations:
Citation
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
Results Reference
result
Links:
URL
https://www.lidsen.com/journals/icm/icm-04-03-054
Description
James et al study link

Learn more about this trial

Multidisciplinary Intervention for Mild Cognitive Impairment

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