Cognitive DysfunctionNCT05504811
FitMi AD Home Therapy for Individuals With MCI or Mild Dementia Due to Alzheimer's Disease
A study testing FitMi AD and Conventional exercise program in people with Cognitive Dysfunction and Dementia, Mild, run by Flint Rehabilitation Devices, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cognitive Dysfunction, Dementia, Mild
- What is being tested?
- FitMi AD and Conventional exercise program
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2023to 12 Mar 2025
- Phase
- Interventional
- 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
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rancho Research Institute, Inc
Downey, California, 90242
About this study
Official title: FitMi AD: a Safe and Motivating Computer-guided Exercise System for Individuals With MCI or Mild Dementia Due to 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 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.
- Conditions
- Cognitive Dysfunction, Dementia, Mild
- Being tested
- FitMi AD, Conventional exercise program
- Medical subject headings
- Cognitive Dysfunction, Dementia, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitMi ADDevice
Exercise using the motion sensing devices and a tablet computer
Conventional exercise programOther
Exercise following printed sheets or booklet
| Study group | Role | What they receive |
|---|---|---|
| Experimental: FitMi AD Exercise Program | Experimental | 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. Receives: Device: FitMi AD |
| Active Comparator: Conventional booklet of exercise program | Active comparator | 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. Receives: Other: Conventional exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Reach Test
How far can someone reach while standing in a fixed position
Measured: Baseline, Immediately Post-Treatment (an average of 3 months)
Change in Timed Up and Go Test
Time it takes to stand up from a chair and walk a short distance
Measured: Baseline, Immediately Post-Treatment (an average of 3 months)
Change in 30 Second Chair Stand Test
How many times someone stand up from a chair in 30 seconds
Measured: Baseline, Immediately Post-Treatment (an average of 3 months)
Secondary outcomes (1)
Duration of Exercise Performed
Duration of exercise performed over intervention period.
Measured: Immediately Post-Treatment (an average of 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start8 Sep 2023
- Primary completion12 Mar 2025
- Study completion12 Mar 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 Cognitive DysfunctionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flint Rehabilitation Devices, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rancho Research Institute, Inc.
- Responsible party
- Sponsor
- Investigators
- Freddi Segal-Gidan, PA, PhD, Principal investigator, Rancho Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504811
- Sponsor's protocol ID
- 2R44AG063651-02
- Status last verified
- Sep 2024
- First submitted
- 12 Aug 2022
- Last updated
- 20 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FitMi AD: a Safe and Motivating Computer-guided Exercise System for Individuals With MCI or Mild Dementia Due to Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05504811
- Acronym / sponsor ID
- 2R44AG063651-02
- Conditions
- Cognitive Dysfunction, Dementia, Mild
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Flint Rehabilitation Devices, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Rancho Research Institute, Inc.
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Posted 20 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: FitMi AD Exercise Program | Experimental | Device: FitMi ADParticipants 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. |
| Active Comparator: Conventional booklet of exercise program | Active comparator | Other: Conventional exercise programParticipants 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 may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| FitMi ADExercise using the motion sensing devices and a tablet computer | Device | Experimental: FitMi AD Exercise Program |
| Conventional exercise programExercise following printed sheets or booklet | Other | Active Comparator: Conventional booklet of exercise program |
Primary outcome
Change in Functional Reach Test
Time frame: Baseline, Immediately Post-Treatment (an average of 3 months)
How far can someone reach while standing in a fixed position
Change in Timed Up and Go Test
Time frame: Baseline, Immediately Post-Treatment (an average of 3 months)
Time it takes to stand up from a chair and walk a short distance
Change in 30 Second Chair Stand Test
Time frame: Baseline, Immediately Post-Treatment (an average of 3 months)
How many times someone stand up from a chair in 30 seconds
1 secondary outcome
Duration of Exercise Performed
Time frame: Immediately Post-Treatment (an average of 3 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cognitive Dysfunction
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
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.
Freddi Segal-Gidan, PA, PhD principal investigator
Rancho Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FitMi AD and Conventional exercise program in people with Cognitive Dysfunction and Dementia, Mild, run by Flint Rehabilitation Devices, LLC at 1 site in United States.
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 20 Jul 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 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?
Change in Functional Reach Test (time frame: Baseline, Immediately Post-Treatment (an average of 3 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2026.