Preventing Medication Mismanagement in People Living With Dementia

NCT07600684 | Recruiting

• 1 other identifier: 5R44AG077737-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dementia

Keywords

dementia; cognitive impairment; self-medicating device; compliance

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baesline, 4, 8, and 12 month timepoints

Study Arms (2)

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.

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.

Interventions

HiDO HomeCareSystem DEVICE

Participants randomized to the intervention arm will receive and be trained on the HiDO HCS Device and will have medication dispensed via this technology.

HiDO HomeCare System

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HiDO Technologies: lead
• University of California, Davis: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

HiDO Technologies

Folsom, California, 95762, United States

RECRUITING

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; Patient Compliance

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Charles Gellman

CONTACT

510-813-7224; charles@hidohealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 22, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)