Recruiting

Preventative Dementia Treatments

Sponsor:

VA Office of Research and Development

Code:

NCT06451874

Conditions

Motoric Cognitive Risk Syndrome

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Functional Power Training (FPT)

Music-Based Digital Therapy (MBDT)

FPT + MBDT

Study Details

Brief summary:

This study will begin to evaluate personalized preventative dementia treatments for Veterans at risk for developing dementia. The investigators will target Veterans with Motoric Cognitive Risk syndrome (MCR), which is characterized by slow gait speed and cognitive concerns (e.g., problems with memory or concentrations).

Conditions

Motoric Cognitive Risk Syndrome

Study ID

NCT06451874

Start date

Jul 1, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 65
2. Receiving VA primary care
3. Community-dwelling
4. Motoric Cognitive Risky Syndrome i. Slow gait speed ii. Subjective cognitive concerns/complaints

Exclusion Criteria:

1. Non-English speaking
2. Presence of a terminal disease
3. Major medical problem
4. Myocardial infarction or major surgery in the previous 3 months
5. 3-point walking pattern
6. Dementia diagnostic
7. Mobility disability

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Stage 1 Exercise Treatment

Participants will first be randomized to 6-week exercise treatment (FPT or MBDT)

experimental: Stage 2: Exercise Treatment

At 6-week, responsiveness (change in gait speed = 0.05 m/s) will be evaluated. Responders will continue with their assigned treatment and non-responders will be randomized to either continue assigned treatment or combined treatment for an additional 6 weeks.

Interventions

Functional Power Training (FPT)

Participants will receive twice weekly FPT, a progressive functional-based exercises that target optimizing leg force production and leg velocity.

Music-Based Digital Therapy (MBDT)

Participants will receive twice weekly MBDT, a technology-driven gait training that is grounded in evidence-based rehabilitation treatment, rhythmic auditory stimulation.

FPT + MBDT

For non-responders who were randomized to augment treatment, they will receive combined FPT and MBDT treatment.

Primary outcome measure

  • Enrollment/Baseline [ Time Frame: Enrollment ]
  • Retention [ Time Frame: Baseline to end of 12-week treatment ]
  • Compliance [ Time Frame: Baseline to end of 12-week treatment ]
  • Acceptability [ Time Frame: End of 12-week treatment ]

Central Contacts and Locations

Central contacts

Elisa Ogawa, PhD MS BS

(857) 364-4011elisa.ogawa@va.gov

Locations

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Recruiting

Boston, Massachusetts, United States, 02130-4817

Contacts

Elisa Ogawa, PhD MS BS

857-364-4011elisa.ogawa@va.gov

Principal Investigator:

Elisa Ogawa, PhD MS BS

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Keywords

  • Veterans
  • Mobility
  • Cognition
  • Sequential Multiple Assignment Randomized Trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-07-02.