N/A
N=5,325
Digital Detection of Dementia (D Cubed) Studies: D2
Alzheimer Disease and Related Dementias (ADRD)
Bottom Line
View on ClinicalTrials.gov: NCT05231954 ↗Enrolled (actual)
5,325
Serious AEs
33.3%
Results posted
Aug 2025
Primary outcome: Primary: 12-Month Cumulative Incidence of ADRD Diagnoses — 213; 134; 355 Number of new ADRD cases — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Passive Digital Marker for screening for ADRD (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 12-Month Cumulative Incidence of ADRD Diagnoses |
213; 134; 355 | 0.006 sig |
| SECONDARY 12-Month Cumulative Incidence of ADRD Services |
879; 636; 1366 | 0.044 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 65 years or older
- At least one visit to primary care practice within the past year
- Ability to provide informed consent
- Ability to communicate in English or Spanish
- Available EHR data from at least the past three years
Exclusion Criteria
- Prior ADRD or mild cognitive impairment diagnosis as determined by ICD-10 code
- Evidence of any history of prescription for a cholinesterase inhibitors or memantine.
- Has serious mental illness such as bipolar or schizophrenia as determined by ICD-10 code
- Permanent resident of a nursing facility
Data sourced from ClinicalTrials.gov (NCT05231954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.