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Diagnostic Test

Digital Screening Tools for Dementia (Dcubed Trial)

N/A
Recruiting
Led By Malaz Boustani, MD, MPH
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
65 years or older
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Dcubed Trial Summary

This trial will test whether a PDM or QDRS can help reduce the rate of new ADRD diagnosis in primary care practices.

Who is the study for?
This trial is for individuals aged 65 or older who have visited a primary care practice in the past year, can consent to participate, and communicate in English or Spanish. They must have electronic health records from at least the last three years. Those with prior dementia diagnoses, certain medication histories, or serious mental illnesses are excluded.Check my eligibility
What is being tested?
The study is testing a Passive Digital Marker (PDM) and Quick Dementia Rating System (QDRS), alone and combined, to see if they help detect Alzheimer's Disease and Related Dementias (ADRD) more effectively during routine primary care visits.See study design
What are the potential side effects?
Since this trial involves digital screening tools rather than medications, traditional side effects are not applicable. However, there may be privacy concerns related to data collection or potential stress due to monitoring.

Dcubed Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 65 years old or older.

Dcubed Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of ADRD
Secondary outcome measures
Incidence of ADRD services

Dcubed Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Passive Digital Marker (PDM)Experimental Treatment1 Intervention
Passive Digital Marker (PDM): Electronic Health Record Data from those clinics randomized to PDM will be run through the PDM, a machine learning algorithm which can predict ADRD one year and three years prior to its onset.
Group II: Annual Well Visit or any other visit to Primary Care DoctorActive Control1 Intervention
Annual Well Visit or any other visit to Primary Care Doctor: This is the usual care arm. Electronic Health Record Data for patients from the clinics randomized to usual care will be collected for comparison with the other 2 arms. Patients from these primary care clinics must have had a visit to their doctor either as an annual well visit (AWV) or any other type of visit. These clinics will not have to do anything for the study but run their business as usual without altering anything.
Group III: Passive Digital Marker (PDM) + Quick Dementia Rating Scale (QDRS)Active Control1 Intervention
Patients in the primary care clinics randomized to PDM+QDRS will have Electronic Health Record Data of their patients run through the PDM, a machine learning algorithm which can predict ADRD one year and three years prior to its onset. In addition, patients from these clinics will have their patients complete the QDRS, a validated patient reported outcome (PRO) tool. This combined approach will assess the value of early detection of ADRD and if the annual well visit can overcome the barriers related to early detection of ADRD.

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
980 Previous Clinical Trials
979,832 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,013,913 Total Patients Enrolled
Malaz Boustani, MD, MPHPrincipal InvestigatorIndiana University
9 Previous Clinical Trials
15,454 Total Patients Enrolled

Media Library

Passive Digital Marker for screening for ADRD (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT05231954 — N/A
Caregiver Research Study Groups: Annual Well Visit or any other visit to Primary Care Doctor, Passive Digital Marker (PDM), Passive Digital Marker (PDM) + Quick Dementia Rating Scale (QDRS)
Caregiver Clinical Trial 2023: Passive Digital Marker for screening for ADRD Highlights & Side Effects. Trial Name: NCT05231954 — N/A
Passive Digital Marker for screening for ADRD (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05231954 — N/A
Caregiver Patient Testimony for trial: Trial Name: NCT05231954 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity to join this trial at present?

"As the clinicaltrials.gov portal confirms, this medical experiment is actively seeking participants. The trial was initially released on July 5th 2022 and has since been modified on September 7th 2022."

Answered by AI

What is the total number of participants in this clinical research study?

"Indeed, clinicaltrials.gov data confirms that this research is actively recruiting participants; it was initially posted on July 5th 2022 and last updated September 7th of the same year. Approximately 2600 patients must be recruited from two distinct medical centres."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
What site did they apply to?
University of Miami School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

My mom has Parkinsons with Dementia.
PatientReceived 1 prior treatment
~1537 spots leftby Dec 2025