Multidisciplinary Intervention for Mild Cognitive Impairment

NCT ID: NCT02943187

Last Updated: 2021-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2022-06-30

Brief Summary

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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

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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).

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive training

Intervention Type BEHAVIORAL

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

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type BEHAVIORAL

Nutrition

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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True Life Medicine

UNKNOWN

Sponsor Role collaborator

Gibson Institute of Cognitive Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christina Ledbetter, PhD

Role: PRINCIPAL_INVESTIGATOR

Gibson Institute of Cognitive Research

Amy L Moore, PhD

Role: STUDY_DIRECTOR

Gibson Institute of Cognitive Research

Randolph James, MD

Role: PRINCIPAL_INVESTIGATOR

True Life Medicine

Dick M Carpenter, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Colorado Springs

Locations

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Gibson Institute of Cognitive Research

Colorado Springs, Colorado, United States

Site Status

Countries

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United States

References

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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

Reference Type RESULT

Related Links

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Other Identifiers

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GICR-1012

Identifier Type: -

Identifier Source: org_study_id

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