Multidisciplinary Intervention for Mild Cognitive Impairment

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02943187

Acronym

(MCI)

Enrollment

Registered

2016-10-24

Start date

2016-10-31

Completion date

2022-06-30

Last updated

2021-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

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).

Interventions

BEHAVIORALCognitive 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_SUPPLEMENTNutrition

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Evidence of overall cognitive function improvement	within 14 days after completing the intervention	Confirmed by change in pretest to post-test scores on the Dementia Rating Scale (DRS-2)

Secondary

Measure	Time frame	Description
Evidence of improvement in executive function	within 14 days after completing the intervention	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	within 14 days after completing the intervention	As confirmed by pretest to post-test changes on a Trail Making Test
Evidence of change in brain function	within 30 days after completing the intervention	Confirmed by change in pretest to post-test neuroimaging using MRI
Evidence of improvement in visual attention	with 14 days after completing the intervention	Confirmed by change in pretest to post-test scores on the Conners Continous Performance Test (CPT-3)
Evidence of improvement in auditory attention	with 14 days after completing the intervention	Confirmed by change in pretest to post-test scores on the Auditory Attention Test (CATA)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026