CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5,325 enrolled
Drug / intervention
Passive Digital Marker for screening for ADRDother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05231954
NCT05231954N/ACompleted
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Digital Detection of Dementia (D Cubed) Studies: D2

Indiana University·interventional·Posted Feb 9, 2022·Updated Aug 20, 2025

In Brief

A clinical study evaluating Passive Digital Marker for screening for ADRD for Alzheimer Disease and Related Dementias (ADRD). Completed, enrolled 5,325 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease and Related Dementias (ADRD)
CountriesUnited States
CollaboratorsNational Institute on Aging (NIA)

Timeline

N/ACompletedFinished
20222023202420252026
First PostedFeb 9, 2022
Enrollment StartJul 5, 2022
Primary CompletionJul 5, 2024
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 4.4 years ago

Interventions

Passive Digital Marker for screening for ADRDother

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.