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Digital Detection of Dementia (D Cubed) Studies: D2

NCT05231954 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5325

Last updated 2025-08-20

Study results available
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Summary

The specific aim of the pragmatic trial is to evaluate the practical utility and effect of the PDM, the QDRS, and the combined approach (PDM + QDRS) in improving the annual rate of new documented ADRD diagnosis in primary care practices.

Conditions

  • Alzheimer Disease and Related Dementias (ADRD)

Interventions

OTHER

Passive Digital Marker for screening for ADRD

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.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Indiana University

    lead OTHER

Principal Investigators

  • Malaz Boustani, MD, MPH · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-05
Primary Completion
2024-07-05
Completion
2024-07-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05231954 on ClinicalTrials.gov