Multidisciplinary Intervention for Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

— (MCI)  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02943187
• Other study ID #: GICR-1012
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2016
• Est. completion date: June 2022

Study information

• Verified date: July 2021
• Source: Gibson Institute of Cognitive Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: June 2022
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
United States	Gibson Institute of Cognitive Research	Colorado Springs	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Gibson Institute of Cognitive Research	True Life Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Medicin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Evidence of change in brain function	Confirmed by change in pretest to post-test neuroimaging using MRI	within 30 days after completing the intervention
Secondary	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
Secondary	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

External Links

•   James et al study link