DementiaNCT07600684
Preventing Medication Mismanagement in People Living With Dementia
A study testing HiDO HomeCareSystem in people with Dementia, run by HiDO Technologies at 1 site in United States.
Trial summary
The purpose of this research is to learn whether the HiDO-ALZ device can improve medication compliance and health outcomes in participants with dementia that need to take daily medication. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- HiDO HomeCareSystem
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Participants must have a diagnosis of dementia.
- They must be prescribed one medication indicated for dementia symptoms such as Aricept, Namenda, or Donepezil, and be prescribed at least one additional medication.
- Participants must have an active study partner that is willing to be enrolled into the study and willing to receive messages and alerts from the HiDO-ALZ system if medications are missed. The study partner must also agree to complete surveys about the participant's ongoing health.
- Participants must be willing to allow research staff to enter their homes to install the HiDO-ALZ device and to complete study activities.
- The participant's medications will be reviewed by the UCD pharmacist prior to randomization. If a participant has contraindicated medication(s), this medication will need to be removed or justified by the prescribing clinician prior to randomization. The research team and HiDO staff will work with the UCD pharmacist and prescribing clinician to resolve contraindicated medications prior to randomization. If a resolution is not possible, the participant will not be enrolled.
- •MoCA score of 15 to 22 or previous MMSE score of 21 to 26 within the last 6 months.
- If no test is available, the participants will be given a MoCA test after signing consent to confirm eligibility.
Who cannot join
- The inability to demonstrate capacity to consent or assent as determined by the Capacity Assessment Checklist.
- Individuals who do not have a study partner/caregiver (e.g., spouse, adult child) to complete questionnaires.
- Participants with MoCA scores below 15 will be excluded as they may not be able to use the device independently.
- Participants who are unable or unwilling to complete the cognitive testing or unwilling to complete the blood tests.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
HiDO Technologies
Folsom, California, 95762
Charles Gellman, 5138137224, charles@hidohealth.com
Lisa Marceau, 4014284197, lmarceau@alphamhealth.com
About this study
Official title: Preventing Medication Mismanagement in People Living With Dementia Through Automated Medication Dispensing With Facial Recognition and Video Observation
The purpose of this research is to learn whether the HiDO-ALZ device can improve medication compliance and health outcomes in participants with dementia that need to take daily medication.
Read the detailed description
The Phase II SBIR goal is to enhance, validate, \& commercialize HiDO-ALZ, an automated, secure, artificial intelligence (AI) driven medication delivery \& observation platform to maximize therapy compliance \& health outcomes in dementia. Dementia and Alzheimer's disease (AD) negatively impact medication management. The development of novel AI technology to improve independent patient adherence to complex medication schedules and remote reporting of compliance metrics to caregivers \& providers would significantly optimize patient care and reduce healthcare costs. The aim of this project is to test the functionality of the HiDO-ALZ technology in participants with dementia or symptoms of dementia as determined by current cognitive function. An additional goal of this study is to determine the adherence rates and efficiency of the system in this population. The hypothesis is that participants with dementia will have better medication compliance as compared to baseline prior to the implementation of the technology, and better than that of the control group. The HiDO-ALZ platform will solve these challenges by automating medication administration for people with dementia (PwD) to eliminate mismanagement, decrease caregiver burden, reduce healthcare utilization, and facilitate PwD to age in place. HiDO-ALZ is an automated, AI driven medication dispensing and direct observation platform to optimize medication adherence. The device integrates medication dispensing, dose administration time, medication synchronization, and a pair of front-facing cameras to validate the right meds, right route, right time, right dosage to the right patient (5R's). Cameras record every dose using facial recognition \& provide real-time medication consumption recordings. Through cloud connectivity, caregivers have access to video observation logs, dose administration time, adherence trends, and longitudinal adherence via web dashboard.
- Conditions
- Dementia
- Being tested
- HiDO HomeCareSystem
- Keywords
- dementia, cognitive impairment, self-medicating device, compliance
- Medical subject headings
- Dementia, Cognitive Dysfunction, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HiDO HomeCareSystemDevice
Participants randomized to the intervention arm will receive and be trained on the HiDO HCS Device and will have medication dispensed via this technology.
| Study group | Role | What they receive |
|---|---|---|
| HiDO HomeCare System | Active comparator | The HiDO HomeCare System (HCS) is a medication dispensation device that participants will interface with via face recognition at the time they are expected to take medication. HCS is tool that can assist participants and their care partners remember and monitor medication dosing. Receives: Device: HiDO HomeCareSystem |
| Standard Medication Management | No intervention | Participants randomized to Standard Medication Management will continue taking medication as usual, without the assitance of the HiDO HCS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 12 months in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a standardized assessment used to evaluate the severity of cognitive dysfunction. The total score is derived from multiple cognitive domains, including memory, language, praxis, and orientation. Change from baseline to the specified assessment timepoint will be analyzed, with higher scores indicating greater cognitive impairment.
Measured: baseline and 12-months
Change From Baseline to 12 months for Everyday Cognition (ECog) Total Score
Everyday Cognition (ECog) is a validated questionnaire used to assess cognitively relevant functional abilities in older adults across multiple domains. The ECog total score will be calculated based on participant responses, with higher scores indicating greater perceived cognitive decline. Change from baseline to the specified assessment timepoint will be analyzed.
Measured: Baesline, 4, 8, and 12 month timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start5 May 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HiDO Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Davis, National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600684
- Sponsor's protocol ID
- 5R44AG077737-03
- Other IDs
- 5R44AG077737-03
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access will be limited to the study team, approved development personnel at HiDO Technologies, and affiliated clinical researchers involved in the design and analysis of future studies. No third-party or external access will be granted without appropriate IRB review.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Medication Mismanagement in People Living With Dementia Through Automated Medication Dispensing With Facial Recognition and Video Observation
- ClinicalTrials.gov ID
- NCT07600684
- Acronym / sponsor ID
- 5R44AG077737-03
- Conditions
- Dementia
- Keywords
- dementia, cognitive impairment, self-medicating device, compliance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- HiDO TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- University of California, Davis, National Institute on Aging (NIA)
- Study start
- 5 May 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to learn whether the HiDO-ALZ device can improve medication compliance and health outcomes in participants with dementia that need to take daily medication.
Detailed description
The Phase II SBIR goal is to enhance, validate, \& commercialize HiDO-ALZ, an automated, secure, artificial intelligence (AI) driven medication delivery \& observation platform to maximize therapy compliance \& health outcomes in dementia. Dementia and Alzheimer's disease (AD) negatively impact medication management. The development of novel AI technology to improve independent patient adherence to complex medication schedules and remote reporting of compliance metrics to caregivers \& providers would significantly optimize patient care and reduce healthcare costs. The aim of this project is to test the functionality of the HiDO-ALZ technology in participants with dementia or symptoms of dementia as determined by current cognitive function. An additional goal of this study is to determine the adherence rates and efficiency of the system in this population. The hypothesis is that participants with dementia will have better medication compliance as compared to baseline prior to the implementation of the technology, and better than that of the control group. The HiDO-ALZ platform will solve these challenges by automating medication administration for people with dementia (PwD) to eliminate mismanagement, decrease caregiver burden, reduce healthcare utilization, and facilitate PwD to age in place. HiDO-ALZ is an automated, AI driven medication dispensing and direct observation platform to optimize medication adherence. The device integrates medication dispensing, dose administration time, medication synchronization, and a pair of front-facing cameras to validate the right meds, right route, right time, right dosage to the right patient (5R's). Cameras record every dose using facial recognition \& provide real-time medication consumption recordings. Through cloud connectivity, caregivers have access to video observation logs, dose administration time, adherence trends, and longitudinal adherence via web dashboard.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HiDO HomeCare System | Active comparator | Device: HiDO HomeCareSystemThe HiDO HomeCare System (HCS) is a medication dispensation device that participants will interface with via face recognition at the time they are expected to take medication. HCS is tool that can assist participants and their care partners remember and monitor medication dosing. |
| Standard Medication Management | No intervention | –Participants randomized to Standard Medication Management will continue taking medication as usual, without the assitance of the HiDO HCS. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Participants must have a diagnosis of dementia.
- They must be prescribed one medication indicated for dementia symptoms such as Aricept, Namenda, or Donepezil, and be prescribed at least one additional medication.
- Participants must have an active study partner that is willing to be enrolled into the study and willing to receive messages and alerts from the HiDO-ALZ system if medications are missed. The study partner must also agree to complete surveys about the participant's ongoing health.
- Participants must be willing to allow research staff to enter their homes to install the HiDO-ALZ device and to complete study activities.
- The participant's medications will be reviewed by the UCD pharmacist prior to randomization. If a participant has contraindicated medication(s), this medication will need to be removed or justified by the prescribing clinician prior to randomization. The research team and HiDO staff will work with the UCD pharmacist and prescribing clinician to resolve contraindicated medications prior to randomization. If a resolution is not possible, the participant will not be enrolled.
Key exclusion criteria (4 listed)
- The inability to demonstrate capacity to consent or assent as determined by the Capacity Assessment Checklist.
- Individuals who do not have a study partner/caregiver (e.g., spouse, adult child) to complete questionnaires.
- Participants with MoCA scores below 15 will be excluded as they may not be able to use the device independently.
- Participants who are unable or unwilling to complete the cognitive testing or unwilling to complete the blood tests.
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 |
|---|---|---|
| HiDO HomeCareSystemParticipants randomized to the intervention arm will receive and be trained on the HiDO HCS Device and will have medication dispensed via this technology. | Device | HiDO HomeCare System |
Primary outcome
Change From Baseline to 12 months in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score
Time frame: baseline and 12-months
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a standardized assessment used to evaluate the severity of cognitive dysfunction. The total score is derived from multiple cognitive domains, including memory, language, praxis, and orientation. Change from baseline to the specified assessment timepoint will be analyzed, with higher scores indicating greater cognitive impairment.
Change From Baseline to 12 months for Everyday Cognition (ECog) Total Score
Time frame: Baesline, 4, 8, and 12 month timepoints
Everyday Cognition (ECog) is a validated questionnaire used to assess cognitively relevant functional abilities in older adults across multiple domains. The ECog total score will be calculated based on participant responses, with higher scores indicating greater perceived cognitive decline. Change from baseline to the specified assessment timepoint will be analyzed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. Access will be limited to the study team, approved development personnel at HiDO Technologies, and affiliated clinical researchers involved in the design and analysis of future studies. No third-party or external access will be granted without appropriate IRB review.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HiDO HomeCareSystem in people with Dementia, run by HiDO Technologies 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 7 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: looking for participants now, as of the sponsor's last update on 22 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles Gellman (510-813-7224, charles@hidohealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to 12 months in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score (time frame: baseline and 12-months). The study lists 2 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 22 May 2026.