NCT02943187

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

2.2 years

First QC Date

October 21, 2016

Last Update Submit

July 26, 2021

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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 change in brain function

    within 30 days after completing the intervention

  • Evidence of improvement in visual attention

    with 14 days after completing the intervention

  • Evidence of improvement in auditory attention

    with 14 days after completing the intervention

Study Arms (1)

Nutrition and Cognitive Training

EXPERIMENTAL

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 trainingDietary Supplement: Nutrition

Interventions

Cognitive trainingBEHAVIORAL

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.

Nutrition and Cognitive Training
NutritionDIETARY_SUPPLEMENT

Participants will be given dietary recommendations and nutritional supplements to optimize cognition.

Nutrition and Cognitive Training

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50+ previously diagnosed with MCI
  • Living in the greater Colorado Springs area

You may not qualify if:

  • No braces, metal implants, or claustrophobia that would contraindicate magnetic resonance imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gibson Institute of Cognitive Research

Colorado Springs, Colorado, 80919, United States

Location

Related 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 Medicine, 4(3). doi: 10.21926/obm.icm.1903054 Retrieved from https://www.lidsen.com/journals/icm/icm-04-03-054

    RESULT

Related Links

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive TrainingNutritional Status

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Christina Ledbetter, PhD

    Gibson Institute of Cognitive Research

    PRINCIPAL INVESTIGATOR

  • Amy L Moore, PhD

    Gibson Institute of Cognitive Research

    STUDY DIRECTOR

  • Randolph James, MD

    True Life Medicine

    PRINCIPAL INVESTIGATOR

  • Dick M Carpenter, PhD

    University of Colorado, Colorado Springs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2016

First Posted

October 24, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2018

Study Completion

June 1, 2022

Last Updated

July 27, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

Harvard Dataverse

Locations

US(1)