Recruiting

HiDO-ALZ

Sponsor:

HiDO Technologies

Code:

NCT07600684

Conditions

Dementia

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

HiDO HomeCareSystem

Study Details

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

Study ID

NCT07600684

Start date

May 5, 2026

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: HiDO HomeCare System

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.

no intervention: Standard Medication Management

Participants randomized to Standard Medication Management will continue taking medication as usual, without the assitance of the HiDO HCS.

Interventions

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 measure

  • Change From Baseline to 12 months in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score [ Time Frame: baseline and 12-months ]
  • Change From Baseline to 12 months for Everyday Cognition (ECog) Total Score [ Time Frame: Baesline, 4, 8, and 12 month timepoints ]

Central Contacts and Locations

Central contacts

Locations

HiDO Technologies

Recruiting

Folsom, California, United States, 95762

Contacts

Principal Investigator:

Charles Gellman

More Information

Sponsor

HiDO Technologies

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • dementia
  • cognitive impairment
  • self-medicating device
  • compliance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by HiDO Technologies on 2026-05-22.