70 Participants Needed

Automated Medication Dispensing for Dementia

Age: 65+
Sex: Any
Trial Phase: Phase 2
Sponsor: HiDO Technologies
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is automated medication dispensing safe for people with dementia?

The research on automated medication dispensing for people with dementia shows that it can help manage medication use safely, as it reduces potentially inappropriate medications and anticholinergic burden (side effects from certain drugs). However, more studies with larger groups are needed to confirm these safety benefits.12345

How does the HiDO-ALZ treatment differ from other dementia treatments?

The HiDO-ALZ treatment is unique because it involves automated medication dispensing, which can help ensure that patients with dementia receive their medications on time and in the correct dosage, potentially improving adherence and reducing caregiver burden.678910

What data supports the effectiveness of the treatment HiDO-ALZ for dementia?

Research shows that using an automatic medication dispenser (AMD) can help people with Alzheimer's disease stick to their medication schedule and reduce the burden on caregivers. This suggests that automated systems like HiDO-ALZ might be effective in managing medication for dementia patients.89101112

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Field Efficacy Study - Experimental GroupExperimental Treatment1 Intervention
Group II: Field Efficacy Study - Control GroupActive Control1 Intervention

Find a Clinic Near You

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

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.
The "portable" CDR: translating the clinical dementia rating interview into a PDA format.Galvin, JE., Meuser, TM., Coats, MA., et al.[2021]
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.
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]
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.
Comparative cardiovascular safety of dementia medications: a cross-national study.Fosbøl, EL., Peterson, ED., Holm, E., et al.[2018]

Citations

The "portable" CDR: translating the clinical dementia rating interview into a PDA format. [2021]
Persistence with cholinesterase inhibitor therapy for dementia: an observational administrative health database study. [2022]
Older Adults with Alzheimer's Disease Who Have Used an Automatic Medication Dispenser for 3 or More Years. [2020]
Assessing change in cognitive function in dementia: the relative utilities of the Alzheimer's Disease Assessment Scale-Cognitive Subscale and the Cognitive Drug Research system. [2013]
Persons with mild and moderate Alzheimer's disease use verbal-instruction technology to manage daily activities: effects on performance and mood. [2022]
Automated multi-dose dispensing in persons with and without Alzheimer's disease-impacts on pharmacotherapy. [2022]
Evaluation of the Effect of a Safe Medication Strategy on Potentially Inappropriate Medications, Polypharmacy and Anticholinergic Burden for People with Dementia: An Intervention Study. [2023]
Comparative cardiovascular safety of dementia medications: a cross-national study. [2018]
Concomitant use of anticholinergics with acetylcholinesterase inhibitors in Medicaid recipients with dementia and residing in nursing homes. [2009]
10.United Statespubmed.ncbi.nlm.nih.gov
Treatment Patterns with Antidementia Drugs in the United States: Medicare Cohort Study. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Dementia diagnoses from clinical and neuropsychological data compared: the Cache County study. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
A randomized trial of a web-based platform to help families manage dementia-related behavioral symptoms: The WeCareAdvisor™. [2022]
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