NCT07600684 · HiDO Technologies
Preventing Medication Mismanagement in People Living With Dementia
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
HiDO HomeCareSystem
Participants randomized to the intervention arm will receive and be trained on the HiDO HCS Device and will have medication dispensed via this technology.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Folsom, California
Collaborators
University of California, Davis, National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations