FitMi AD Home Therapy for Alzheimer's Disease

Overseen By Ian Russell, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Flint Rehabilitation Devices, LLC

Disqualifiers: Wheelchair use, Neurologic conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new exercise device called FitMi AD for individuals with mild cognitive impairment or mild dementia due to Alzheimer’s. The device tracks movement as users follow exercises on a computer. The trial compares this device to traditional exercise programs from a booklet. It suits those who can see and hear well enough to use a tablet and have someone to assist with daily living questions. Participants should commit to a 30-minute daily exercise routine for three months. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance exercise options for cognitive health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the FitMi AD device is safe for individuals with mild cognitive impairment or mild dementia?

Research has shown that the FitMi AD Home Therapy is a safe and encouraging exercise system for individuals with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease. This therapy uses a computer-guided exercise device, deemed safe for users. Available information does not report any negative effects or safety issues. The treatment involves no drugs or invasive procedures, reducing the risk of serious side effects. For those considering joining a trial with FitMi AD, this background suggests it is generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FitMi AD Home Therapy because it introduces an interactive and tech-driven approach to Alzheimer's care. Unlike traditional exercise programs that rely on booklets, FitMi AD uses interactive pucks and a tablet to guide and monitor exercises, making the process more engaging and potentially more effective. This innovative method not only aims to improve adherence to exercise routines but also offers real-time feedback and tracking, which could lead to more personalized and effective exercise regimens for individuals with Alzheimer's disease.

What evidence suggests that the FitMi AD device is effective for Alzheimer's disease?

Research shows that regular exercise can improve thinking and memory in people with mild memory problems or early-stage dementia. In this trial, participants will join one of two groups. The FitMi AD Home Therapy, one of the study treatments, enhances exercise enjoyment by using sensors to track movements and provide feedback. Studies have found that physical activity can slow memory loss in people with Alzheimer's. The FitMi device aims to boost this effect by offering interactive exercises that are both enjoyable and challenging. Meanwhile, participants in the other group will follow a conventional exercise program using a booklet. Although direct evidence for FitMi AD is limited, its method relies on strong evidence that exercise benefits brain health in Alzheimer's patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Freddi Segal-Gidan, PA, PhD

Principal Investigator

Rancho Research Institute, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals over 50 with mild cognitive impairment or mild dementia due to Alzheimer's, who can see and hear well enough to follow on-screen instructions. They must have support from someone who knows about their daily living skills.

Inclusion Criteria

I can see clearly and hear well.

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

Presence of other severe concurrent medical conditions that may prevent the participants from completing the 3-month study

I have a neurological condition like a movement disorder or a history of stroke.

I am under 50 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform exercises using either the FitMi AD device or a conventional exercise booklet for 3 months

12 weeks

Daily home exercises

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Conventional exercise program
• FitMi AD Home Therapy

Trial Overview The study tests a new exercise device called FitMi AD against conventional exercises. FitMi AD tracks movements during computer-guided exercises designed for those with cognitive impairments.

How Is the Trial Designed?

Group I: Experimental: FitMi AD Exercise Program Experimental Treatment 1 Intervention

Participants will perform exercises by interacting with FitMi pucks, as described and monitored on a tablet computer. Participants will be asked to exercise at least 30 minutes per day for 3 months.

Group II: Active Comparator: Conventional booklet of exercise program Active Control 1 Intervention

Participants will perform exercises described in a booklet similar to what is typically provided to individuals. Participants will be asked to exercise at least 30 minutes per day for 3 months.

Who Is Running the Clinical Trial?

Flint Rehabilitation Devices, LLC

Lead Sponsor

Trials

7

Recruited

240+

Rancho Research Institute, Inc.

Collaborator

Trials

9

Recruited

560+

Citations

1. trialx.com trialx.com/clinical-trials/listings/228832/fitmi-ad-home-therapy-for-individuals-with-mci-or-mild-dementia-due-to-alzheimers-disease/

FitMi AD Home Therapy for Individuals With MCI or Mild ... This study will investigate the efficacy of a newly developed exercise device (FitMi AD) for individuals with mild cognitive impairment (MCI) or ...

2. withpower.com withpower.com/trial/phase-1-cognitive-dysfunction-8-2022-e8ad5

FitMi AD Home Therapy for Alzheimer's Disease This study will investigate the efficacy of a newly developed exercise device (FitMi AD) for individuals with mild cognitive impairment (MCI) or mild ...

3. nia.nih.gov nia.nih.gov/research/ongoing-AD-trials

NIA-Funded Active Alzheimer's and Related Dementias ... FitMi AD Home Therapy for Individuals With MCI or Mild Dementia Due to Alzheimer's Disease ... outcomes for nursing home residents with Alzheimer's disease ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/condition/11/alzheimers-disease?activelyRecruiting=false&page=318

Alzheimer's Disease Clinical Research Trials FitMi AD Home Therapy for Individuals with MCI or Mild Dementia Due to Alzheimer's Disease. Phase. N/A. Span. 112 weeks. Sponsor. Flint Rehabilitation Devices ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01689948

Alzheimer Disease : Rehabilitation's Intervention at Home Outpatients non-drug therapies represent a potential support that adapts to patient with an AD or mixed dementia, especially in their milder ...

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0046569

Mild Dementia (DBCOND0046569) Increase scalability & security by streamlining data sharing ... FitMi AD Home Therapy for Individuals With MCI or Mild Dementia Due to Alzheimer's Disease ...

7. iadrp.nia.nih.gov iadrp.nia.nih.gov/project/fitmi-ad-safe-and-motivating-computer-guided-exercise-system-individuals-mci-or-mild

FitMi AD: a safe and motivating computer-guided exercise ... A safe and motivating computer-guided exercise system for individuals with MCI or mild dementia due to Alzheimer's disease.