Alzheimer DiseasePhase 2NCT06691256
Preventing Medication Mismanagement in People Living With Dementia Through Automated Medication Dispensing With Facial Recognition and Video Observation
A Phase 2 study testing HiDO-ALZ in people with Alzheimer Disease and Dementia, run by HiDO Technologies at 1 site in United States.
Trial summary
Globally, >47M individuals live with dementia, with new incidence of 7.7M annually. Medication mismanagement is one of the most common and concerning risk factors in people with dementia (PwD), as it leads to undertreatment, emergency room visits, hospital admissions/readmissions, and serious adverse events. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease, Dementia, Medication Adherence
- What is being tested?
- HiDO-ALZ
- 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 Sep 2024to 30 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 aged 65 or older.
- Diagnosed with both dementia and diabetes, with documented difficulty in maintaining at least one health marker (such as glucose, HbA1c, cholesterol, blood pressure, or weight) within target levels over the past 18-24 months.
- Mild cognitive impairment or early-stage dementia, as verified by a Montreal Cognitive Assessment (MoCA) score between 18 and 24.
Who cannot join
- Cognitive deficits or serious mental health or medical conditions that would compromise safety or the reliability of feedback.
- Contraindications to taking low-dose Vitamin C (100 mg).
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Globally, >47M individuals live with dementia, with new incidence of 7.7M annually. Medication mismanagement is one of the most common and concerning risk factors in people with dementia (PwD), as it leads to undertreatment, emergency room visits, hospital admissions/readmissions, and serious adverse events. 3M older U.S. adults are admitted to nursing homes due to drug-related adherence problems with costs >$14B/year. Furthermore, 30% of hospital admissions of older adults are drug related with 11% attributed to medication non-adherence and 17% to adverse drug reactions. While Alzheimer's disease (AD) \& type 2 diabetes mellitus (DM) individually have considerable morbidity \& mortality, they often occur together, worsening adverse outcomes, quality of life, \& care costs. This is especially true as the AD/DM combination creates a complex balancing act of med management \& symptom monitoring in older populations. While the goal is to keep older adults with dementia at home as long as possible, these challenges lead to untold personal \& family suffering, as well as billions in potentially avoidable healthcare costs annually. The HiDO-ALZ platform will solve these challenges by automating medication administration for PwD to eliminate mismanagement, decrease caregiver burden, reduce healthcare utilization, and facilitate PwD to age in place. HiDO is being developed as an automated, AI driven medication dispensing and direct observation platform to optimize adherence. The device integrates medication dispensing, dose administration time, medication synchronization, \& 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, providers \& caregivers have access to video observation logs, dose administration time, adherence trends, \& longitudinal adherence via web dashboard. Patients \& caregivers can easily setup complex medication protocols in minutes using a smartphone app. The device then alerts patients and dispenses up to 7 different types of meds simultaneously, with up to 90 days of medication. Connected data sources including remote blood pressure and weight measurements, as well as electronic health record lab results and videoconferencing integrate in a single dashboard. The project will build on successful Phase I, in which the medication dispensing unit was updated with modifications for dementia, passed all bench testing, and was successfully validated in pilot usability with dementia subjects. Phase II will expand the foundation with four Aims: 1) Enhance device with remote sensors for diabetes management, expanded data integration, and video conferencing, 2) Test enhanced platform for usability in dementia subjects, 3) Transition the design to formal manufacturing process to ensure system meets performance standards and regulatory requirements \& produce pre-production devices for testing, \& 4) Conduct in-home clinical trial to demonstrate adherence and efficacy.
- Being tested
- HiDO-ALZ
- Keywords
- people with dementia (PwD), Dementia, Alzheimer Disease, Medication Management, Medication Adherence, Type 2 diabetes mellitus
- Medical subject headings
- Alzheimer Disease, Dementia, Medication Adherence, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HiDO-ALZDevice
HiDO-ALZ platform, an AI-driven medication dispensing and observation system designed to improve adherence in individuals with dementia and diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Field Efficacy Study - Experimental Group | Experimental | Participants in the experimental group will receive the HiDO-ALZ platform for 12 months, which provides automated medication dispensing, real-time facial recognition to ensure correct medication delivery, and biometric monitoring for blood pressure and weight. This arms plan to recruit up to 25 participants aged 65 or older, along with their caregivers, to assess the usability and human factors of the HiDO-ALZ platform. Receives: Device: HiDO-ALZ |
| Field Efficacy Study - Control Group | No intervention | Participants in the control group will receive standard care without the HiDO-ALZ device. They will continue with their usual medication routines and any standard biometric monitoring methods as directed by their healthcare providers. This arms plan to recruit up to 25 participants aged 65 or older, along with their caregivers, to assess the standard of care and not using the HiDO-ALZ device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence: Percentage of Doses Taken as Prescribed Over 12 Months
The primary outcome focuses on improving medication adherence among participants using the HiDO-ALZ system, as compared to standard care. Medication adherence is measured through the system's automated monitoring, which utilizes facial recognition to verify identity and track each dose administered. The HiDO-ALZ platform records the timing and accuracy of each dose taken, providing a comprehensive adherence rate over the study period. This adherence data will be evaluated against adherence rates in the standard care group, aiming to demonstrate the system's effectiveness in reducing missed doses and optimizing medication management for individuals with dementia.
Measured: Measurements are collected daily and weekly over 12 months.
Change in Health Biomarker: Change in Glucose Levels (mg/dL) Over 12 Months
This outcome measures the average change in blood glucose levels for participants in the experimental group using the HiDO-ALZ system compared to the control group receiving standard care. Blood glucose levels will be measured at baseline, 6 months, and 12 months, with the change calculated as the difference from baseline to each subsequent time point.
Unit of Measure: Milligrams per Deciliter (mg/dL)
Measured: Measurements are collected at baseline, 6 months, and 12 months for both adherence and biomarker levels.
Change in Health Biomarker: Change in HbA1c Levels (%) Over 12 Months
This outcome measures the average change in HbA1c levels for participants in the experimental group compared to the control group. HbA1c levels will be monitored at baseline, 6 months, and 12 months, with changes calculated as the difference from baseline.
Unit of Measure: Percentage (%)
Measured: Measurements are collected at baseline, 6 months, and 12 months for both adherence and biomarker levels.
Change in Health Biomarker: Change in Creatinine Levels (mg/dL) Over 12 Months
This outcome measures the average change in serum creatinine levels for participants in the experimental group compared to the control group. Measurements will be taken at baseline, 6 months, and 12 months, with changes calculated from baseline values.
Unit of Measure: Milligrams per Deciliter (mg/dL)
Measured: Measurements are collected at baseline, 6 months, and 12 months for both adherence and biomarker levels.
Change in Health Biomarker: Change in Glomerular Filtration Rate (GFR) (mL/min/1.73 m²) Over 12 Months
This outcome measures the average change in GFR, an indicator of kidney function, for participants in the experimental group compared to the control group. Measurements will be taken at baseline, 6 months, and 12 months, with changes calculated from baseline values.
Unit of Measure: Milliliters per Minute per 1.73 m² (mL/min/1.73 m²)
Measured: Measurements are collected at baseline, 6 months, and 12 months for both adherence and biomarker levels.
Secondary outcomes (3)
Monthly Weight Tracking
Weight will be tracked monthly for participants in the experimental group using Bluetooth-enabled devices integrated with the HiDO-ALZ platform. The weight data, recorded in kilograms, will provide insights into any weight changes over the 12-month study period, aiding in the assessment of overall health status.
Measured: Measurements are taken monthly over the 12-month study duration.
Blood Pressure Monitoring (mmHg)
Blood pressure will be measured monthly for each participant using Bluetooth-enabled devices connected to the HiDO-ALZ system. Data, recorded in mmHg, will include both systolic and diastolic values to monitor blood pressure trends and assess the intervention's impact on cardiovascular health over time.
Measured: Measurements are taken monthly over the 12-month study duration.
Monthly Heart Rate Tracking (beats per minute)
Heart rate will be recorded monthly in beats per minute (bpm) for participants in the experimental group through Bluetooth-enabled devices connected to the HiDO-ALZ platform. Monthly tracking will allow for the evaluation of heart rate stability and potential changes associated with the intervention.
Measured: Measurements are taken monthly over the 12-month study duration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start5 Sep 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Phase 2 study model for HiDO-ALZ uses a dual-study approach to refine and validate the platform: Field Efficacy Study: Building on in-clinic findings, this home-based trial enrolls participants in a 12-month randomized controlled study to assess the HiDO-ALZ's impact on medication adherence and health outcomes, such as adherence rates and biometric trends.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- HiDO Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rush University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691256
- Sponsor's protocol ID
- R44AG077737
- Status last verified
- Oct 2026
- First submitted
- 10 Nov 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 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
- NCT06691256
- Acronym / sponsor ID
- R44AG077737
- Keywords
- people with dementia (PwD), Dementia, Alzheimer Disease, Medication Management, Medication Adherence, Type 2 diabetes mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- HiDO TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Rush University Medical Center
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 15 Nov 2024 (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.
Globally, >47M individuals live with dementia, with new incidence of 7.7M annually. Medication mismanagement is one of the most common and concerning risk factors in people with dementia (PwD), as it leads to undertreatment, emergency room visits, hospital admissions/readmissions, and serious adverse events. 3M older U.S. adults are admitted to nursing homes due to drug-related adherence problems with costs >$14B/year. Furthermore, 30% of hospital admissions of older adults are drug related with 11% attributed to medication non-adherence and 17% to adverse drug reactions. While Alzheimer's disease (AD) \& type 2 diabetes mellitus (DM) individually have considerable morbidity \& mortality, they often occur together, worsening adverse outcomes, quality of life, \& care costs. This is especially true as the AD/DM combination creates a complex balancing act of med management \& symptom monitoring in older populations. While the goal is to keep older adults with dementia at home as long as possible, these challenges lead to untold personal \& family suffering, as well as billions in potentially avoidable healthcare costs annually. The HiDO-ALZ platform will solve these challenges by automating medication administration for PwD to eliminate mismanagement, decrease caregiver burden, reduce healthcare utilization, and facilitate PwD to age in place. HiDO is being developed as an automated, AI driven medication dispensing and direct observation platform to optimize adherence. The device integrates medication dispensing, dose administration time, medication synchronization, \& 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, providers \& caregivers have access to video observation logs, dose administration time, adherence trends, \& longitudinal adherence via web dashboard. Patients \& caregivers can easily setup complex medication protocols in minutes using a smartphone app. The device then alerts patients and dispenses up to 7 different types of meds simultaneously, with up to 90 days of medication. Connected data sources including remote blood pressure and weight measurements, as well as electronic health record lab results and videoconferencing integrate in a single dashboard. The project will build on successful Phase I, in which the medication dispensing unit was updated with modifications for dementia, passed all bench testing, and was successfully validated in pilot usability with dementia subjects. Phase II will expand the foundation with four Aims: 1) Enhance device with remote sensors for diabetes management, expanded data integration, and video conferencing, 2) Test enhanced platform for usability in dementia subjects, 3) Transition the design to formal manufacturing process to ensure system meets performance standards and regulatory requirements \& produce pre-production devices for testing, \& 4) Conduct in-home clinical trial to demonstrate adherence and efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Phase 2 study model for HiDO-ALZ uses a dual-study approach to refine and validate the platform: Field Efficacy Study: Building on in-clinic findings, this home-based trial enrolls participants in a 12-month randomized controlled study to assess the HiDO-ALZ's impact on medication adherence and health outcomes, such as adherence rates and biometric trends.
| Arm | Type | Receives |
|---|---|---|
| Field Efficacy Study - Experimental Group | Experimental | Device: HiDO-ALZParticipants in the experimental group will receive the HiDO-ALZ platform for 12 months, which provides automated medication dispensing, real-time facial recognition to ensure correct medication delivery, and biometric monitoring for blood pressure and weight. This arms plan to recruit up to 25 participants aged 65 or older, along with their caregivers, to assess the usability and human factors of the HiDO-ALZ platform. |
| Field Efficacy Study - Control Group | No intervention | –Participants in the control group will receive standard care without the HiDO-ALZ device. They will continue with their usual medication routines and any standard biometric monitoring methods as directed by their healthcare providers. This arms plan to recruit up to 25 participants aged 65 or older, along with their caregivers, to assess the standard of care and not using the HiDO-ALZ device. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Participants aged 65 or older.
- Diagnosed with both dementia and diabetes, with documented difficulty in maintaining at least one health marker (such as glucose, HbA1c, cholesterol, blood pressure, or weight) within target levels over the past 18-24 months.
- Mild cognitive impairment or early-stage dementia, as verified by a Montreal Cognitive Assessment (MoCA) score between 18 and 24.
Key exclusion criteria (2 listed)
- Cognitive deficits or serious mental health or medical conditions that would compromise safety or the reliability of feedback.
- Contraindications to taking low-dose Vitamin C (100 mg).
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-ALZHiDO-ALZ platform, an AI-driven medication dispensing and observation system designed to improve adherence in individuals with dementia and diabetes. | Device | Field Efficacy Study - Experimental Group |
Primary outcome
Medication adherence: Percentage of Doses Taken as Prescribed Over 12 Months
Time frame: Measurements are collected daily and weekly over 12 months.
The primary outcome focuses on improving medication adherence among participants using the HiDO-ALZ system, as compared to standard care. Medication adherence is measured through the system's automated monitoring, which utilizes facial recognition to verify identity and track each dose administered. The HiDO-ALZ platform records the timing and accuracy of each dose taken, providing a comprehensive adherence rate over the study period. This adherence data will be evaluated against adherence rates in the standard care group, aiming to demonstrate the system's effectiveness in reducing missed doses and optimizing medication management for individuals with dementia.
Change in Health Biomarker: Change in Glucose Levels (mg/dL) Over 12 Months
Time frame: Measurements are collected at baseline, 6 months, and 12 months for both adherence and biomarker levels.
This outcome measures the average change in blood glucose levels for participants in the experimental group using the HiDO-ALZ system compared to the control group receiving standard care. Blood glucose levels will be measured at baseline, 6 months, and 12 months, with the change calculated as the difference from baseline to each subsequent time point. Unit of Measure: Milligrams per Deciliter (mg/dL)
Change in Health Biomarker: Change in HbA1c Levels (%) Over 12 Months
Time frame: Measurements are collected at baseline, 6 months, and 12 months for both adherence and biomarker levels.
This outcome measures the average change in HbA1c levels for participants in the experimental group compared to the control group. HbA1c levels will be monitored at baseline, 6 months, and 12 months, with changes calculated as the difference from baseline. Unit of Measure: Percentage (%)
Change in Health Biomarker: Change in Creatinine Levels (mg/dL) Over 12 Months
Time frame: Measurements are collected at baseline, 6 months, and 12 months for both adherence and biomarker levels.
This outcome measures the average change in serum creatinine levels for participants in the experimental group compared to the control group. Measurements will be taken at baseline, 6 months, and 12 months, with changes calculated from baseline values. Unit of Measure: Milligrams per Deciliter (mg/dL)
Change in Health Biomarker: Change in Glomerular Filtration Rate (GFR) (mL/min/1.73 m²) Over 12 Months
Time frame: Measurements are collected at baseline, 6 months, and 12 months for both adherence and biomarker levels.
This outcome measures the average change in GFR, an indicator of kidney function, for participants in the experimental group compared to the control group. Measurements will be taken at baseline, 6 months, and 12 months, with changes calculated from baseline values. Unit of Measure: Milliliters per Minute per 1.73 m² (mL/min/1.73 m²)
3 secondary outcomes
Monthly Weight Tracking
Time frame: Measurements are taken monthly over the 12-month study duration.
Blood Pressure Monitoring (mmHg)
Time frame: Measurements are taken monthly over the 12-month study duration.
Monthly Heart Rate Tracking (beats per minute)
Time frame: Measurements are taken monthly over the 12-month study duration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HiDO-ALZ in people with Alzheimer Disease and 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 3 inclusion and 2 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 7 Oct 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Medication adherence: Percentage of Doses Taken as Prescribed Over 12 Months (time frame: Measurements are collected daily and weekly over 12 months.). The study lists 5 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 7 Oct 2026.