Automated Medication Dispensing for Dementia

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: HiDO Technologies

Disqualifiers: Cognitive deficits, Serious mental health, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called HiDO-ALZ, which helps people with dementia manage their medications automatically. The device ensures medications are taken correctly and on time, while also tracking health indicators like blood pressure and weight. The trial seeks participants who are 65 or older, have both dementia and diabetes, and have struggled to maintain health markers like blood sugar or blood pressure within target levels. Participants will either use the HiDO-ALZ platform or continue their usual care to assess the device's effectiveness in improving medication management. As a Phase 2 trial, this research measures the HiDO-ALZ device's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in dementia care.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop your current medications. However, since the trial involves an automated medication dispensing system, it's likely that you will continue taking your current medications as part of the study.

What prior data suggests that the HiDO-ALZ device is safe for individuals with dementia?

Research has shown that the HiDO-ALZ platform is being tested to help people with dementia manage their medications more easily. This system uses technology to dispense medications and verify correct intake. In earlier tests, the device was adjusted for dementia patients and functioned well without causing problems.

The current phase of testing focuses on how well people can use the device without major issues. Since this trial is in Phase 2, the device has already demonstrated some safety in humans during initial tests. This phase typically examines any side effects and how well patients handle using the device. So far, there have been no major reports of serious side effects.

Overall, the HiDO-ALZ platform is undergoing testing to ensure it is safe and easy to use for helping people with dementia manage their medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HiDO-ALZ because it offers a high-tech solution to medication management for people with dementia, a task typically handled manually by caregivers. Unlike current treatments that rely on routine pill-taking and basic monitoring, HiDO-ALZ automates medication dispensing and uses real-time facial recognition to ensure the right person gets the right medication. It also includes biometric monitoring to track vital signs like blood pressure and weight, providing a more comprehensive approach to managing the health of individuals with dementia. This innovative platform could transform how medication adherence is managed, making it easier and safer for both patients and caregivers.

What evidence suggests that the HiDO-ALZ device is effective for improving medication adherence in dementia patients?

Research has shown that automatic medication dispensers can significantly help people with dementia adhere to their medication schedules. In this trial, participants in the experimental group will receive the HiDO-ALZ system, which uses smart technology to ensure timely medication delivery. It includes features like facial recognition and video recordings to confirm proper medication intake. Early results suggest this could reduce hospital visits and improve the quality of life for both patients and caregivers. The system also manages other health issues, such as diabetes, by consolidating all health information in one place. This simplifies tasks for caregivers and helps patients remain at home longer. Participants in the control group will continue with their usual medication routines and standard care without the HiDO-ALZ device. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with dementia, such as Alzheimer's Disease, who also may have type 2 diabetes. Participants should struggle with medication management and adherence. They must be able to use the HiDO-ALZ device which dispenses medications automatically using facial recognition and video monitoring.

Inclusion Criteria

Mild cognitive impairment or early-stage dementia, as verified by a Montreal Cognitive Assessment (MoCA) score between 18 and 24

I am 65 years old or older.

I have dementia and diabetes and struggle to keep my health markers like glucose or blood pressure in target ranges.

Exclusion Criteria

Cognitive deficits or serious mental health or medical conditions that would compromise safety or the reliability of feedback

I cannot take low-dose Vitamin C due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the experimental group receive the HiDO-ALZ platform for automated medication dispensing and monitoring over 12 months

12 months

Monthly in-home visits for monitoring and data collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HiDO-ALZ

Trial Overview The HiDO-ALZ platform is being tested to see if it can help people with dementia manage their medications better by automating dispensing and providing caregivers access to adherence data through a cloud-connected dashboard.

How Is the Trial Designed?

Group I: Field Efficacy Study - Experimental Group Experimental Treatment 1 Intervention

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.

Group II: Field Efficacy Study - Control Group Active Control 1 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 Is Running the Clinical Trial?

HiDO Technologies

Lead Sponsor

Trials

2

Recruited

80+

Rush University Medical Center

Collaborator

Trials

448

Recruited

247,000+

Published Research Related to This Trial

WeCareAdvisor™ is a web-based platform designed to help families manage dementia-related behavioral symptoms by providing knowledge, daily tips, and tailored treatment plans, and is currently being tested in a randomized trial with 57 caregivers.

The trial aims to assess the platform's acceptability and usability, as well as its immediate impact on caregiver confidence and the frequency of behavioral symptoms, with participants receiving support through check-in calls during the treatment phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of a web-based platform to help families manage dementia-related behavioral symptoms: The WeCareAdvisor™. Gitlin, LN., Kales, HC., Marx, K., et al.[2022]

A computer-generated version of the Clinical Dementia Rating (CDR) was developed and tested using data from 138 evaluations, showing excellent internal consistency and interrater reliability, making it a reliable tool for assessing cognitive impairment in Alzheimer's disease.

The software-based CDR demonstrated strong discriminative ability between demented and nondemented individuals, with an area under the curve of 0.95, indicating it is an effective alternative to traditional paper-based methods for clinical and research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The "portable" CDR: translating the clinical dementia rating interview into a PDA format. Galvin, JE., Meuser, TM., Coats, MA., et al.[2021]

In a study of 46,737 Medicare beneficiaries and 29,496 Danish participants, cholinesterase inhibitors like donepezil showed similar cardiovascular safety profiles, with no significant differences in the risk of myocardial infarction (MI) or heart failure compared to other medications.

Memantine was linked to a higher risk of fatal or nonfatal MI and cardiac death in the Danish cohort, as well as increased all-cause mortality in both cohorts, suggesting that patients prescribed memantine may have been sicker overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative cardiovascular safety of dementia medications: a cross-national study. Fosbøl, EL., Peterson, ED., Holm, E., et al.[2018]

Verbal-instruction technology significantly helped individuals with mild and moderate Alzheimer's disease perform daily activities, with seven out of nine participants showing accurate performance in tasks like snack preparation and shaving.

The intervention also positively impacted mood, as eight participants exhibited increased happiness or decreased unhappiness during the activities, suggesting that this approach can enhance both activity engagement and emotional well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persons with mild and moderate Alzheimer's disease use verbal-instruction technology to manage daily activities: effects on performance and mood. Lancioni, G., Singh, N., O'Reilly, M., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11196749

Project Details - NIH RePORTER The Phase II SBIR goal is to enhance, validate, & commercialize HiDO-ALZ, an automated, secure, artificial intelligence (AI) driven medication delivery & ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06691256

Preventing Medication Mismanagement in People Living ... The primary outcome focuses on improving medication adherence among participants using the HiDO-ALZ system, as compared to standard care. Medication adherence ...

3. withpower.com withpower.com/trial/automated-medication-dispensing-for-dementia-77291

Automated Medication Dispensing for Dementia What data supports the effectiveness of the treatment HiDO-ALZ for dementia? Research shows that using an automatic medication dispenser (AMD) can help ...

4. alz.org alz.org/getmedia/ef8f48f9-ad36-48ea-87f9-b74034635c1e/alzheimers-facts-and-figures.pdf

2025 Alzheimer's Disease Facts and Figures 2025 Alzheimer's Disease Facts and Figures is a statistical resource for U.S. data related to Alzheimer's disease, the.

5. alz.org alz.org/research/for_researchers/grants/funded-studies-search

Search Our Funded Studies Search for Alzheimer's and dementia research studies funded by the Alzheimer's Association International Research Grant Program.

6. reporter.nih.gov reporter.nih.gov/project-details/11003943

Project Details HiDO is being developed as an automated, AI driven medication dispensing and direct observation platform to optimize adherence.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06691256/preventing-medication-mismanagement-in-people-living-with-dementia-through-automated-medication-dispensing-with-facial-recognition-and-video-observation

Preventing Medication Mismanagement in People Living ... The HiDO-ALZ platform will solve these challenges by automating medication administration for PwD to eliminate mismanagement, decrease caregiver ...