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DementiaeRADARNCT05905796

The Brain Health Study: A Pragmatic, Patient-Centered Trial

A study testing Brain Health Assessment in people with Dementia and Alzheimer Disease, run by University of California, San Francisco at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The eRADAR Brain Health Study is an embedded, pragmatic clinical trial to determine whether targeted screening for dementia using the eRADAR algorithm increases dementia detection within primary care compared to usual care. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Dementia, Alzheimer Disease
What is being tested?
Brain Health Assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,261 participants
Where
3 sitesUnited States
Study dates
7 Dec 2022to 26 Jan 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • No prior diagnosis of dementia (defined from EHR diagnosis codes) and not receiving medications for dementia
  • Active patient at participating clinic
  • Adequate data to calculate eRADAR score

Who cannot join

  • Currently receiving hospice care

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • UCSF Primary Care at China Basin

    San Francisco, California, 94107

  • Division of General Internal Medicine

    San Francisco, California, 94115

  • Women's Health Primary Care

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: Low-cost Detection of Dementia Using Electronic Health Records Data: Validation and Testing of the Electronic Health Record Risk of Alzheimer's and Dementia Assessment Rule (eRADAR) Algorithm in a Pragmatic, Patient-centered Trial.

The eRADAR Brain Health Study is an embedded, pragmatic clinical trial to determine whether targeted screening for dementia using the eRADAR algorithm increases dementia detection within primary care compared to usual care.

Read the detailed description

eRADAR stands for "electronic health record (EHR) Risk of Alzheimer's and Dementia Assessment Rule." It is a low-cost tool or algorithm that uses readily available EHR data elements to identify patients at risk of undiagnosed dementia. The investigators will conduct a pragmatic randomized controlled trial to assess the impact of implementing eRADAR as part of a supported outreach process on dementia detection rates. The investigators will also explore the impact of eRADAR implementation on healthcare utilization and patient experience.

Being tested
Brain Health Assessment
Medical subject headings
Dementia, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brain Health AssessmentOther

    Research interventionists, who will be trained and licensed health practitioners (e.g., social workers), will ask participants about changes in memory or thinking and daily function, screen for depression, and administer a standard cognitive screening test. Research interventionalists will use a standardized note template to document results in the participant's EHR. Research interventionists will notify participants and PCPs if follow-up is recommended.

Study groups in NCT05905796
Study groupRoleWhat they receive
Brain Health InterventionExperimentalParticipants in the intervention arm were invited to attend a "brain health" visit with a trained research interventionist who was a licensed clinician (e.g., social worker.) They were sent a mailed outreach letter and information sheet, with follow-up phone calls. At the visit, the research interventionist asked about memory symptoms and ability to perform instrumental activities of daily living (IADLs) and screened for cognitive impairment and depression. Results were shared with the participant and their primary care physician (PCP), who was responsible for follow up and more evaluation if needed and for making a final diagnosis of dementia, if applicable.
Receives: Other: Brain Health Assessment
Usual CareNo interventionIndividuals in this arm did not receive any intervention but rather usual care. University of California, San Francisco (UCSF) does not routinely screen for cognitive impairment (in line with current guidelines from the US Preventive Services Task Force).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. New Diagnoses of Dementia (12 Months)

    Number of patients who received new dementia diagnoses within 12 months, identified from the electronic health record (EHR) using a prespecified set of ICD-10 codes

    Measured: 12 months after index date

Secondary outcomes (12)

  1. New Diagnoses of Dementia or Mild Cognitive Impairment (12 Months)

    Number of patients who received a new diagnosis of dementia or mild cognitive impairment within 12 months, defined from EHR data

    Measured: 12 months after index date

  2. New Diagnoses of Dementia (18 Months)

    Number of patients who received a new diagnosis of dementia within 18 months of index date, defined from EHR data

    Measured: 18 months after index date

  3. New Diagnoses of Dementia (6 Months)

    Number of patients receiving new dementia diagnoses within 6 months of index date, defined using EHR data

    Measured: 6 months after index date

  4. New Dementia Medications (12 Months)

    Number of patients who received a new medication for dementia in 12 months, defined from medication orders or dispensings in the electronic health record

    Measured: 12 months after index date

  5. Urgent Care or Emergency Department Visits (12 Months)

    Number of patients who had at least 1 urgent care or emergency department visit in the 12 months following their index date

    Measured: 12 months after index date

  6. Hospitalizations and Inpatient Admissions (12 Months)

    Average number of hospitalizations and inpatient stays per participant within 12 months of index date

    Measured: 12 months after index date

  7. Scheduled Visits Missed (12 Months)

    Average number of scheduled clinic visits missed ("no shows") per participant

    Measured: 12 months after index date

  8. Primary Care Visits (6 Months)

    Average number of visits per participant in primary care within 6 months after the index date

    Measured: 6 months after index date

  9. Primary Care Visits (12 Months)

    Average number of primary care visits per participant in the 12 months after their index date

    Measured: 12 months after index date

  10. B-12 Lab Tests (12 Months)

    Number of patients with at least one B12 lab test in the 12 months after their index date

    Measured: 12 months after index date

  11. Neuroimaging Tests (12 Months)

    Number of patients with at least one neuroimaging study (CT head, MRI brain) in the 12 months after their index date

    Measured: 12 months after index date

  12. Neurology Referrals (12 Months)

    Number of patients with at least one referral to Neurology or the Memory and Aging Center in the 12 months after their index date

    Measured: 12 months after index date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start7 Dec 2022
  3. Primary completion6 Oct 2025
  4. Study completion26 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,261 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05905796
Sponsor's protocol ID
1R01AG069734
Other IDs
1R01AG069734
Acronym
eRADAR
Status last verified
Sep 2026
First submitted
6 Jun 2023
Last updated
6 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: This Individual Participant Data (IPD) plan applies to all quantitative study data, such as data collected specifically for the study and those derived from electronic health records (EHR), as well as the data collected via planned study surveys, which include only short qualitative free-text fields. The investigators do not plan to share transcripts from in-depth qualitative interviews or recorded study assessment visits. Data will be maintained on secure servers behind the firewalls at the University of California, San Francisco (UCSF). De-identified or limited datasets containing individual-level data on which publications are based will be made available to qualified researchers for specified analyses. The investigators will make the data available to users only under a data-use agreement (DUA).

Publications

  • Dublin S, Greenwood-Hickman MA, Karliner L, Hsu C, Coley RY, Colemon L, Carrasco A, King D, Grace A, Lee SJ, Walsh JME, Barrett T, Broussard J, Singh U, Idu A, Yaffe K, Boustani M, Barnes DE. The electronic health record Risk of Alzheimer's and Dementia Assessment Rule (eRADAR) Brain Health Trial: Protocol for an embedded, pragmatic clinical trial of a low-cost dementia detection algorithm. Contemp Clin Trials. 2023 Dec;135:107356. doi: 10.1016/j.cct.2023.107356. Epub 2023 Oct 17.

    PubMed 37858616

  • Lee SJ, Larson EB, Dublin S, Walker R, Marcum Z, Barnes D. A Cohort Study of Healthcare Utilization in Older Adults with Undiagnosed Dementia. J Gen Intern Med. 2018 Jan;33(1):13-15. doi: 10.1007/s11606-017-4162-3. No abstract available.

    PubMed 28849435

  • Barnes DE, Zhou J, Walker RL, Larson EB, Lee SJ, Boscardin WJ, Marcum ZA, Dublin S. Development and Validation of eRADAR: A Tool Using EHR Data to Detect Unrecognized Dementia. J Am Geriatr Soc. 2020 Jan;68(1):103-111. doi: 10.1111/jgs.16182. Epub 2019 Oct 14.

    PubMed 31612463

  • Coley RY, Smith JJ, Karliner L, Idu AE, Lee SJ, Fuller S, Lam R, Barnes DE, Dublin S. External Validation of the eRADAR Risk Score for Detecting Undiagnosed Dementia in Two Real-World Healthcare Systems. J Gen Intern Med. 2023 Feb;38(2):351-360. doi: 10.1007/s11606-022-07736-6. Epub 2022 Jul 29.

    PubMed 35906516

Questions about this trial

What is this clinical trial studying?

A study testing Brain Health Assessment in people with Dementia and Alzheimer Disease, run by University of California, San Francisco at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

New Diagnoses of Dementia (12 Months) (time frame: 12 months after index date). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05905796, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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