Clinical trial NCT02943187: Multidisciplinary Intervention for Mild Cognitive Impairment
Official title: Novel Functional Medicine Intervention With Cognitive Training for Mild Cognitive Impairment (MCI): A Multiple Baseline Study Across Cases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: Gibson Institute of Cognitive Research
Sponsor class: INDUSTRY
Collaborators: name: True Life Medicine
First posted: 2016-10-24
Enrollment: 5
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Evidence of overall cognitive function improvement
timeFrame: within 14 days after completing the intervention
Secondary outcomes:
measure: Evidence of improvement in executive function
timeFrame: within 14 days after completing the intervention
measure: Evidence of improvement in cognitive flexibility
timeFrame: within 14 days after completing the intervention
measure: Evidence of change in brain function
timeFrame: within 30 days after completing the intervention
measure: Evidence of improvement in visual attention
timeFrame: with 14 days after completing the intervention
measure: Evidence of improvement in auditory attention
timeFrame: with 14 days after completing the intervention
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Gibson Institute of Cognitive Research
state: Colorado
Study officials:
affiliation: Gibson Institute of Cognitive Research
name: Christina Ledbetter, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gibson Institute of Cognitive Research
name: Amy L Moore, PhD
role: STUDY_DIRECTOR
affiliation: True Life Medicine
name: Randolph James, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Colorado Springs
name: Dick M Carpenter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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