Phase 1
N=32
Effects Multimodal Mind and Body Approach for MCI
Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT06814483 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Retention — 11; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Experimental: A computer-based multimodal mind and body approach (cbMMBA) (Behavioral); A standard cognitive training group (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention |
11; 15 | — |
| PRIMARY Fidelity |
25.6; 29.5 | — |
| PRIMARY Satisfaction to Intervention |
4.8; 4.5 | — |
| PRIMARY Number of Participants With Adverse Events |
2; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- report of cognitive decline / complaint by the patient, the patient's informant, or the physician;
- cognitive impairment is confirmed by objective cognitive measures (Montreal Cognitive Assessment (MoCA) and neuropsychological testing), where objective cognitive impairment is defined as poor performance in one or more cognitive measures suggesting deficit in one or more cognitive domains;
- patient has preserved independence in functional abilities (measured by informant report, completion of Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) checklists);
- not demented;
Exclusion Criteria
- has severe visual or hearing impairment;
- has pre-existing musculoskeletal or other conditions, which prohibit BDJ performance and / or the application of acupressure at the selected points;
- has suffered from a neurological disorder (e.g., severe head trauma), psychiatric disease (e.g., major depression), or any other major medical disease that could potentially compromise their cognition;
- has had prior experience with BDJ or acupressure or relaxation techniques in the past year.
Data sourced from ClinicalTrials.gov (NCT06814483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.