NCT06814483

Effects Multimodal Mind and Body Approach for MCI

Completed Phase 1 Results posted Last updated 9 March 2026

What this trial tests

Phase 1 trial testing Experimental: A computer-based multimodal mind and body approach (cbMMBA) in Mild Cognitive Impairment in 32 participants. Completed in 15 July 2025.

Timeline

11 December 2023

Primary endpoint
11 April 2025

15 July 2025

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	32
Start date	11 December 2023
Primary completion	11 April 2025
Estimated completion	15 July 2025
Sites	1 location across United States

Drugs / interventions tested

• Experimental: A computer-based multimodal mind and body approach (cbMMBA)
• A standard cognitive training group

Conditions studied

• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →

Sponsor

Massachusetts General Hospital

Who can join

50 and older, any sex, with Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Retention Primary · Through study intervention, an average of three months

Proportion of subjects who complete all assessments from the total number of subjects started the first intervention

Group	Value	95% CI
A Computer-based Multimodal Mind and Body Approach (cbMMBA)	11
a Standard Cognitive Training	15

Fidelity Primary · Through study interventions, an average of three months

session completed of total 30 classes

Group	Value	95% CI
A Computer-based Multimodal Mind and Body Approach (cbMMBA)	25.6	± 7.9
a Standard Cognitive Training	29.5	± 1.1

Satisfaction to Intervention Primary · Through study interventions, an average of three months

average score in a 1-5 scale, 5 indicates very satisfied with the intervention

Group	Value	95% CI
A Computer-based Multimodal Mind and Body Approach (cbMMBA)	4.8	± 0.42
a Standard Cognitive Training	4.5	± 0.64

Number of Participants With Adverse Events Primary · Through study interventions, an average of three months

Adverse events were assessed by participant self-report at each study visit. An adverse event was defined as any unfavorable or unintended sign, symptom, or medical occurrence temporally associated with study participation, regardless of attribution. This outcome reports the number of participants who experienced ≥1 adverse event during the study period (each participant counted once).

Group	Value	95% CI
A Computer-based Multimodal Mind and Body Approach (cbMMBA)	2
a Standard Cognitive Training	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 month. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

A Computer-based Multimodal Mind and Body Approach (cbMMBA)

Serious: 0/17 (0%)

Deaths: 0/17

a Standard Cognitive Training

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (2 terms — click to expand)

Reaction	System	A Computer-based Multimoda…	a Standard Cognitive Train…
planned heart surgery	Cardiac disorders	—	—
PTSD recurrence	Psychiatric disorders	—	—

Data from ClinicalTrials.gov NCT06814483 adverse events section.

Sponsor's own description

The aim of this application is to develop a computer-based multimodal mind and body approach (CMMBA) for mild cognitive impairment (MCI). This product will provide a new, cost-effective and easily accessible treatment option for MCI and potentially other age-related dementia.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Telehealth-delivered multimodal mind-body intervention for mild cognitive impairment: a randomized feasibility trial toward scalable dementia prevention.
   Liu Y, Hodges S, Wu J, Siegel B, et al · · 2026 · PMID 42238806 · DOI 10.1038/s44400-026-00090-y
2. Telehealth-delivered multimodal mind–body intervention for mild cognitive impairment: a randomized feasibility trial toward scalable dementia prevention
   Liu Y, Hodges S, Wu J, Siegel B, et al · · 2026