Brain Health Assessment for Dementia

(eRADAR Trial)

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

1350 Participants Needed

Trial Summary

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.

Is the Brain Health Assessment for Dementia treatment safe for humans?

The research indicates that adverse drug events (ADEs) are common in patients with dementia, especially when taking multiple medications, with symptoms like drowsiness being frequent. Safety in dementia treatments can be complex, and careful medication review is important to prevent ADEs. ^{1 2 3 4 5}

How does the Brain Health Assessment treatment for dementia differ from other treatments?

The Brain Health Assessment treatment is unique because it focuses on a reliable method for visually inspecting brain MRIs to assess specific brain changes associated with dementia, such as ventricular:brain ratio and white matter changes, which may not be as effectively evaluated by other treatments. ^{6 7 8 9 10}

What is the purpose of this trial?

The eRADAR Brain Health Study seeks to refine and test a novel, low-cost strategy for increasing dementia detection within primary care.

Research Team

Deborah E Barnes, PhD, MPH

Principal Investigator

University of California, San Francisco

Sascha Dublin, MD, PhD

Principal Investigator

KP Washington Health Research Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

References

1. United States 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. [2020]

2. England 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. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Drug Events in Patients with Dementia and Neuropsychiatric/Behavioral, and Psychological Symptoms, a One-Year Prospective Study. [2023]

4. Denmark pubmed.ncbi.nlm.nih.gov

[Adverse events causing discontinuation of donepezil for Alzheimer's dementia]. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Prevalence of adverse drug events and adverse drug reactions in hospital among older patients with dementia: A systematic review. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A method to improve interrater reliability of visual inspection of brain MRI scans in dementia. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Alzheimer's dementia: performance on parallel forms of the dementia assessment battery. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Comparison of magnetic resonance and roentgen ray computed tomography in dementia. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Dementia: diagnosis and evaluation. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

[Neuropsychological examination in evaluating dementia]. [2018]