Brain Health Assessment for Dementia

Not currently recruiting at 4 trial locations
AC
LC
AE
Overseen ByAlana Elop, MS
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Kaiser Permanente
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance dementia detection in primary care by testing a new, cost-effective strategy. Participants will either undergo a brain health assessment—a special evaluation using a score from their health records—or continue with their usual care. Individuals without a dementia diagnosis and not on dementia medications might be suitable, especially if they are active patients at the participating clinic. The goal is to identify potential dementia cases early, enabling doctors to provide timely advice and care. As an unphased trial, this study allows participants to contribute to innovative research that could improve early dementia detection and patient outcomes.

Do I need to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications, but you cannot be on medications for dementia to participate.

What prior data suggests that this Brain Health Assessment is safe for dementia detection?

Research shows that digital tools like the Brain Health Assessment are generally safe and well-liked. These tools can be used from home without supervision, making them easy to use and less stressful. They also help track small changes in brain health over time.

Specific safety details for the Brain Health Assessment are not available, but using electronic health records and brain tests is common in research. These tools are usually non-invasive, meaning they don't involve surgery or entering the body, so they typically have few risks or side effects.

Previous studies have shown that structured brain health programs can effectively slow down memory and thinking problems, suggesting they are safe for most people. Prospective participants should discuss any concerns with the study team or their doctor.12345

Why are researchers excited about this trial?

Researchers are excited about the Brain Health Assessment for dementia because it uses a proactive approach to identify individuals at risk before symptoms become severe. Unlike usual care, which often focuses on managing symptoms after they appear, this method calculates eRADAR scores from electronic health records to pinpoint individuals who may benefit from early intervention. By integrating results directly into the patient’s EHR and sharing them with primary care physicians, this assessment facilitates a more informed and personalized care plan. This innovative approach aims to catch potential issues early, providing a clearer path to effective prevention and management of dementia.

What evidence suggests that the Brain Health Assessment is effective for increasing dementia detection?

Research has shown that assessing brain health can detect early signs of memory and thinking problems related to dementia. In this trial, participants in the Brain Health Intervention arm will undergo a brain health assessment to identify early signs of cognitive decline. One study discovered that a new test identified brain decline in 75% of people with dementia and 44% of those with mild memory issues. Another review highlighted tools that can be used in doctor's offices to check brain health, aiding in early detection. These tests aim to identify at-risk individuals sooner, allowing timely intervention. Early detection is crucial, as only 11.4% of mild memory issues are diagnosed early enough.16789

Who Is on the Research Team?

SD

Sascha Dublin, MD, PhD

Principal Investigator

KP Washington Health Research Institute

DE

Deborah E Barnes, PhD, MPH

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals who are active patients at participating clinics, have not been diagnosed with dementia or Alzheimer's Disease, and aren't on medications for these conditions. They must also have enough data available to calculate what's called an eRADAR score. People currently in hospice care cannot participate.

Inclusion Criteria

I have never been diagnosed with dementia nor am I on dementia medication.
There is enough information to calculate the eRADAR score.
Active patient at participating clinic

Exclusion Criteria

I am currently in hospice care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Brain Health Assessment

Eligible individuals are invited for a brain health assessment visit, and results are entered into the EHR

3 months
1 visit (in-person)

Follow-up

Participants are monitored for new dementia diagnoses and healthcare utilization

12 months

Extended Follow-up

Continued monitoring of healthcare utilization and dementia diagnoses

18 months

What Are the Treatments Tested in This Trial?

Interventions

  • Brain Health Assessment
Trial Overview The study is testing a new strategy to detect dementia early in primary care settings by using a Brain Health Assessment tool. It aims to be low-cost and patient-friendly while improving the identification of cognitive issues.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Brain Health InterventionExperimental Treatment1 Intervention
Group II: Usual careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials
563
Recruited
27,400,000+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

Citations

2025 NIH Alzheimer's Disease and Related Dementias ...Alzheimer's disease and related dementias are complex brain disorders that slowly destroy cognitive functioning — including thinking, ...
Brain health assessment. An exploratory review of tools ...The purpose of this paper is to provide a summary of tools developed for assessing the cognitive dimension of brain health in the out-patient services.
The Brain Health Index: Integrating vulnerability, resilience ...Assessing brain health and identifying cognitive impairment risk remains challenging, with only 11.4% of MCI cases receiving timely ...
BHA‐CS: A novel cognitive composite for Alzheimer's disease ...Reliable decline over one year was detected in 75% of participants with dementia, 44% with MCI, and 3% of CN. Among CN, the Aβ-positive group ...
U.S. POINTER Lifestyle Intervention Improved CognitionTwo lifestyle interventions in U.S. POINTER improved cognition in older adults at risk of cognitive decline. A structured intervention with ...
Data, Assessment, and AnalysisThe BRFSS Cognitive Decline module (PDF) is the only source of state-specific data on cognitive health. The module measures subjective cognitive decline (SCD) — ...
A scoping review of remote and unsupervised digital ...Remote and unsupervised digital assessments can improve scalability, measurement reliability, and ecological validity, enabling the capture of subtle changes.
What the U.S. POINTER results mean for public health ...Top-line results from the study demonstrated that a structured, multi-domain lifestyle intervention significantly reduces cognitive decline ...
Estimating the Prevalence of Dementia and Mild Cognitive ...This cross-sectional study estimates the prevalence of dementia and mild cognitive impairment in the US in 2016 by age, race, ethnicity, ...
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