Brain Health Assessment for Dementia

(eRADAR Trial)

Not currently recruiting at 2 trial locations

Overseen By Leonardo Colemon, MA

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Dementia medications

Disqualifiers: Hospice care

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on finding better ways to detect dementia early in individuals visiting their primary care doctors. It will test a new brain health assessment method to determine if it improves the frequency of dementia identification. Participants will be divided into two groups: one will receive the brain health assessment, while the other will continue with their usual care. This trial suits patients who regularly visit a participating clinic, have not been diagnosed with dementia, and are not taking dementia medications. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research in dementia detection.

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

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

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

Research has shown that brain health tests are generally safe and easy for participants to handle. These tests usually involve non-invasive activities like thinking exercises and brain scans, which typically don't cause side effects. One study on digital tests found that these methods can safely detect small changes in brain health.

Although the specific brain health test used in this trial hasn't been studied before, many similar tests have proven safe in research settings. Since this study focuses on improving detection methods rather than testing a new drug or procedure, the risk of side effects remains low. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Brain Health Assessment for dementia because it offers a proactive approach to identifying and addressing cognitive decline early. Unlike standard treatments that often focus on managing symptoms after diagnosis, this approach uses the innovative eRADAR scoring system to analyze electronic health records (EHRs) and pinpoint individuals who might benefit from early intervention. By integrating brain health assessments directly into regular healthcare visits and providing detailed results to both patients and their primary care physicians, this method aims to catch and address potential issues sooner, potentially slowing the progression of dementia.

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

Studies have shown that checking brain health can improve overall health for people at risk of dementia. For example, one study found that a higher Brain Care Score linked to a much lower risk of developing dementia, especially in younger adults. Experts also say these tests help find problems early without causing anxiety or depression in patients. By spotting issues early, these tests may help delay or slow the progress of dementia. This trial will compare a Brain Health Intervention, which includes calculating eRADAR scores and conducting brain health assessments, with Usual Care. This suggests that brain health checks can be a useful tool in managing and possibly reducing the risk of dementia. ^{6 7 8 9 10}

Who Is on the Research Team?

Sascha Dublin, MD, PhD

Principal Investigator

KP Washington Health Research Institute

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 have not been diagnosed with dementia and are not on any dementia medications. Participants must be active patients at a participating clinic and have enough data available to calculate what's called an eRADAR score. People currently in hospice care cannot join.

Inclusion Criteria

Active patient at participating clinic

I have never been diagnosed with dementia nor am I on dementia medication.

Adequate data to calculate eRADAR score

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

Intervention

Calculate eRADAR scores using EHR data to identify eligible individuals and invite them for a brain health assessment visit

3 months

1 visit (in-person)

Follow-up

Participants are monitored for new dementia diagnosis and healthcare utilization

12 months

Long-term Follow-up

Continued monitoring of dementia diagnosis and healthcare utilization

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Brain Health Assessment

Trial Overview The study is testing a new, cost-effective way to spot dementia early in primary care settings by using something called the Brain Health Assessment, which likely involves tests or questionnaires designed to evaluate memory and thinking skills.

How Is the Trial Designed?

Group I: Brain Health Intervention Experimental Treatment 1 Intervention

Calculate eRADAR scores using EHR data to identify eligible individuals Invite eligible individuals for brain health assessment visit Enter results of brain health assessment visit into EHR Provide summary of results and recommended next steps to the Primary Care Physician and participant

Group II: Usual Care Active Control 1 Intervention

Usual care Individuals who meet eligibility criteria will receive usual care.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

Kaiser Permanente Washington

Collaborator

Trials

3

Recruited

6,500+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a study involving 54 Alzheimer's patients, performance on the Dementia Assessment Battery improved with repeated testing, highlighting the potential for practice effects in cognitive assessments.

The research identified that impairments in visuo-spatial and verbal abilities were independent, with working memory fragility being a key factor in poor recall, emphasizing the need for detailed individual assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alzheimer's dementia: performance on parallel forms of the dementia assessment battery. Teng, EL., Wimer, C., Roberts, E., et al.[2013]

In a study of 123 patients treated with donepezil for Alzheimer's dementia, 21% discontinued treatment due to adverse events (AEs), highlighting the need for careful monitoring during the initial months of therapy.

The most common AEs leading to discontinuation were nausea/vomiting, diarrhea, and loss of appetite, indicating that these side effects are significant considerations in the management of patients on donepezil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse events causing discontinuation of donepezil for Alzheimer's dementia]. Carøe, TK., Moe, C.[2018]

In a study of 710 older patients (aged over 70) admitted to a hospital, 8.6% experienced reported adverse events (RAEs), with patient-related incidents linked to factors like male gender, delirium, and cognitive impairment.

Despite the high incidence of RAEs, which occurred at a rate of 2.1 per person year, these events were not associated with increased mortality during the hospital stay, as 11.1% of patients died regardless of RAE occurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective cohort study of adverse events in older people admitted to the acute general hospital: risk factors and the impact of dementia. Watkin, L., Blanchard, MR., Tookman, A., et al.[2021]

In a survey of 3712 patients, 863 were prescribed anti-dementia drugs, with 21% experiencing confirmed adverse events, primarily excitation/anxiety (45.1%).

Risk factors for these adverse events included polypharmacy (taking 10 or more medications), inappropriate use of anti-dementia drugs, and irregular medication adherence, highlighting the need for careful medication management by healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of and risk factors for adverse events in Alzheimer's patients receiving anti-dementia drugs in at-home care. Imai, H., Hirai, T., Kumazawa, R., et al.[2020]

In a one-year study of 65 older patients with dementia, 81.5% experienced adverse drug events (ADEs), primarily related to medications affecting the nervous system, highlighting the high risk of medication-related issues in this population.

About 58% of the identified ADEs were deemed preventable, emphasizing the importance of interdisciplinary medication reviews to enhance safety and minimize risks, particularly since 27.7% of ADEs resulted in drowsiness, a common concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Drug Events in Patients with Dementia and Neuropsychiatric/Behavioral, and Psychological Symptoms, a One-Year Prospective Study. Hernández, MH., Mestres, C., Modamio, P., et al.[2023]

A systematic review of 5 studies found that the prevalence of adverse drug events (ADEs) in older inpatients with dementia is alarmingly high at 81.5%, indicating a significant safety concern for this population.

The prevalence of adverse drug reactions (ADRs) varied between 12.7% and 24.0%, highlighting the need for better assessment methods and tailored tools to prevent these reactions in older patients with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of adverse drug events and adverse drug reactions in hospital among older patients with dementia: A systematic review. Sakiris, MA., Sawan, M., Hilmer, SN., et al.[2021]

Citations

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Brain health services for the secondary prevention of ... Population-based epidemiological studies have consistently shown a progressively reduced risk of dementia in Western society and, more specifically, Alzheimer's ...