CompletedNot Applicable

FitMi AD Home Therapy for Individuals With MCI or Mild Dementia Due to Alzheimer's Disease

United States31 participantsStarted 2023-09-08

Plain-language summary

This study will investigate the efficacy of a newly developed exercise device (FitMi AD) for individuals with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease. FitMi AD uses embedded sensors that can track and record the patient's direction and degree of movement while performing exercises described on a computer.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * have MCI or mild dementia due to AD (i.e. Clinical Dementia Rating (CDR) score 1 for mild dementia or 0.5 for MCI) * ability to clearly see the screen and hear the audio instructions from the tablet * have a family member or friend who can answer questions about the participant's daily living skills * willing to participate in a research study. Exclusion Criteria: * age \< 50 years old * use of a wheelchair as a primary mobility device (use of a cane or walker is permitted) * presence of other neurologic conditions such as movement disorders or history of stroke * other severe concurrent medical conditions that may prevent the participants from completing the 3-month study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Functional Reach Test

Timeframe: Baseline, Immediately Post-Treatment (an average of 3 months)

Change in Timed Up and Go test

Timeframe: Baseline, Immediately Post-Treatment (an average of 3 months)

Change in 30 second chair stand test

Timeframe: Baseline, Immediately Post-Treatment (an average of 3 months)

Trial details

NCT IDNCT05504811

SponsorFlint Rehabilitation Devices, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-12

View on ClinicalTrials.gov More Cognitive Dysfunction trials

Plain-language summary

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Functional Reach Test

Timeframe: Baseline, Immediately Post-Treatment (an average of 3 months)

Change in Timed Up and Go test

Timeframe: Baseline, Immediately Post-Treatment (an average of 3 months)

Change in 30 second chair stand test

Timeframe: Baseline, Immediately Post-Treatment (an average of 3 months)