Mild Cognitive ImpairmentPhase 1NCT06814483

Effects Multimodal Mind and Body Approach for MCI

A Phase 1 study testing Experimental: A computer-based multimodal mind and body approach (cbMMBA) and A standard cognitive training group in people with Mild Cognitive Impairment, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Mild Cognitive Impairment
What is being tested?: Experimental: A computer-based multimodal mind and body approach (cbMMBA) and A standard cognitive training group
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 11 Dec 2023to 15 Jul 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Charlestown, Massachusetts, 02129

Other trials in United States

About this study

Official title: Modulation Effects of a Computer-based Multimodal Mind and Body Approach for Mild Cognitive Decline

Read the detailed description

The goal of this Phase I R41 (STTR) application is to develop a computer-based multimodal mind and body approach (cbMMBA) to improve the cognitive function for mild cognitive impairment (MCI). This application, if successful, will provide a cost-effective and easily accessible treatment option for MCI and other age-related dementia, significantly improve the prevention of MCI development, and directly benefit patients suffering from the highly prevalent disorder, particularly for those who may have limited access to in-person mind and body interventions.

Conditions: Mild Cognitive Impairment
Being tested: Experimental: A computer-based multimodal mind and body approach (cbMMBA), A standard cognitive training group
Keywords: mind-body intervention, Baduanjin, Cognitive training
Medical subject headings: Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental: A computer-based multimodal mind and body approach (cbMMBA)Behavioural
cbMMBA will include three modules: BDJ, acupressure, and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation.
A standard cognitive training groupBehavioural
The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects

Study groups in NCT06814483
Study group	Role	What they receive
A computer-based multimodal mind and body approach (cbMMBA)	Experimental	cbMMBA will include three modules: BDJ (module 1), acupressure (module 2), and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation Receives: Behavioral: Experimental: A computer-based multimodal mind and body approach (cbMMBA)
a standard cognitive training	Active comparator	The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects Receives: Behavioral: A standard cognitive training group

What is being measured

The primary outcome is the main question the study is designed to answer.

Retention
Proportion of subjects who complete all assessments from the total number of subjects started the first intervention
Measured: Through study intervention, an average of three months
Fidelity
session completed of total 30 classes
Measured: Through study interventions, an average of three months
Satisfaction to Intervention
average score in a 1-5 scale, 5 indicates very satisfied with the intervention
Measured: Through study interventions, an average of three months
Number of Participants With Adverse Events
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).
Measured: Through study interventions, an average of three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Dec 202315 Jul 2025

First posted7 Feb 2025
Study start11 Dec 2023
Primary completion11 Apr 2025
Study completion15 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06814483
Sponsor's protocol ID: 2022p003426
Status last verified: Feb 2026
First submitted: 27 Jan 2025
Last updated: 9 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: The Small Business Act permits SBIR/STTR grantees to withhold data for 4 years after the end of the grant award.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Mild Cognitive Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Modulation Effects of a Computer-based Multimodal Mind and Body Approach for Mild Cognitive Decline
ClinicalTrials.gov ID: NCT06814483
Acronym / sponsor ID: 2022p003426
Conditions: Mild Cognitive Impairment
Keywords: mind-body intervention, Baduanjin, Cognitive training
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 11 Dec 2023 (actual)
Primary completion: 11 Apr 2025 (actual)
Study completion: 15 Jul 2025 (actual)
First posted: 7 Feb 2025 (actual)
Results: Posted 2 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
A computer-based multimodal mind and body approach (cbMMBA)	Experimental	Behavioral: Experimental: A computer-based multimodal mind and body approach (cbMMBA)cbMMBA will include three modules: BDJ (module 1), acupressure (module 2), and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation
a standard cognitive training	Active comparator	Behavioral: A standard cognitive training groupThe program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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;

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Experimental: A computer-based multimodal mind and body approach (cbMMBA)cbMMBA will include three modules: BDJ, acupressure, and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation.	Behavioural	A computer-based multimodal mind and body approach (cbMMBA)
A standard cognitive training groupThe program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects	Behavioural	a standard cognitive training

Primary outcome

Retention
Time frame: 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
Fidelity
Time frame: Through study interventions, an average of three months
session completed of total 30 classes
Satisfaction to Intervention
Time frame: Through study interventions, an average of three months
average score in a 1-5 scale, 5 indicates very satisfied with the intervention
Number of Participants With Adverse Events
Time frame: 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).

Results and safety

Results posted to the registry on 2 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A Computer-based Multimodal Mind and Body Approach (cbMMBA)	17	11
a Standard Cognitive Training	15	15

Primary outcome: Retention

Time frame: Through study intervention, an average of three months. Count of participants. Unit: Participants

Measure	A Computer-based Multimodal Mind and Body Approach (cbMMBA) n = 14	a Standard Cognitive Training n = 15
Value	11	15

Primary outcome: Fidelity

Time frame: Through study interventions, an average of three months. Mean (Standard Deviation). Unit: session

Measure	A Computer-based Multimodal Mind and Body Approach (cbMMBA) n = 17	a Standard Cognitive Training n = 15
Value	25.6 (7.9)	29.5 (1.1)

Primary outcome: Satisfaction to Intervention

Time frame: Through study interventions, an average of three months. Mean (Standard Deviation). Unit: points in a 1-5 scale

Measure	A Computer-based Multimodal Mind and Body Approach (cbMMBA) n = 14	a Standard Cognitive Training n = 15
Value	4.8 (0.42)	4.5 (0.64)

Primary outcome: Number of Participants With Adverse Events

Time frame: Through study interventions, an average of three months. Count of participants. Unit: Participants

Measure	A Computer-based Multimodal Mind and Body Approach (cbMMBA) n = 17	a Standard Cognitive Training n = 15
Value	2	0

Adverse events

Time frame: 6 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A Computer-based Multimodal Mind and Body Approach (cbMMBA)	0 of 17 (0%)	2 of 17 (11.8%)	0 of 17
a Standard Cognitive Training	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. The Small Business Act permits SBIR/STTR grantees to withhold data for 4 years after the end of the grant award.

Related trials for Mild Cognitive Impairment

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RecruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention (time frame: Through study intervention, an average of three months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06814483.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.