Blood Test for Alzheimer's Disease

Overseen By Kelsy Gibson Ferrara, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Qure Healthcare, LLC

Disqualifiers: Neurology certification, Internet access, others

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

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how doctors diagnose and manage Alzheimer's Disease using a special blood test, the Alzheimer's Disease Blood-Based Biomarker Assay. Doctors will first use standard tools and then incorporate additional information from this new test to determine the best course of action for patients with memory problems. The trial includes two groups: one with the new test and one without. Neurologists with 2 to 35 years of experience who frequently see patients at risk for Alzheimer’s are ideal participants. As an unphased trial, this study offers patients the chance to contribute to innovative diagnostic methods that could enhance future Alzheimer's care.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this Alzheimer's Disease Blood-Based Biomarker Assay is safe?

Research has shown that blood tests for Alzheimer's disease, like the one under study, are generally safe. Studies indicate that these tests have minor side effects when used properly. Possible issues include false results, where the test might incorrectly indicate the presence or absence of Alzheimer's. However, serious side effects are rare, with only mild problems like headaches sometimes reported. This type of test is now used to help diagnose Alzheimer's, suggesting it is considered safe for widespread use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Alzheimer's Disease Blood-Based Biomarker Assay because it offers a non-invasive way to detect Alzheimer's disease using a simple blood test. Unlike current methods that rely on more invasive and costly procedures like PET scans and spinal taps, this blood test could provide quicker and easier access to diagnostic information. This innovation could lead to earlier detection and treatment of Alzheimer's, potentially improving outcomes for patients by allowing interventions at an earlier stage of the disease.

What evidence suggests that the Alzheimer's Disease Blood-Based Biomarker Assay is effective for cognitive decline?

This trial will compare the effectiveness of a novel Alzheimer's Disease Blood-Based Biomarker Assay with standard diagnostic tools. Studies have shown that blood tests for Alzheimer's disease can significantly improve diagnosis. Research indicates that these tests correctly identify Alzheimer's in 92% of cases and accurately rule out the disease in 77% of cases, demonstrating reliability in both detection and confirmation. The FDA has approved a blood test to aid in diagnosing Alzheimer's, marking a major advancement. These tests offer a promising new method for early detection and more effective management of Alzheimer's. ^{2 3 6 7 8}

Who Is on the Research Team?

Trever Burgon, PhD

Principal Investigator

QURE Healthcare

Are You a Good Fit for This Trial?

This trial is for neurologists and dementia specialists who will evaluate patient simulations with symptoms of cognitive decline to assess a new blood-based biomarker assay for Alzheimer's disease.

Inclusion Criteria

I am regularly checked for Alzheimer's disease risk.

Access to the internet

Not participating in a clinical research study of the AD assay

Exclusion Criteria

Not practicing in the United States

Board-certified in neurology for less than two years

Unable to read English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Intervention participants complete two rounds of three virtual patient cases with access to standard diagnostic tools and educational material about a novel AD assay

Up to 12 months

Control

Control participants complete two rounds of three virtual patient cases with access to standard diagnostic tools only

Up to 12 months

Follow-up

Participants are monitored for changes in clinical decision-making and quality of care after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alzheimer's Disease Blood-Based Biomarker Assay

Trial Overview The study tests the impact of educational materials and results from a novel Alzheimer's disease blood-based biomarker assay on the clinical decisions made by healthcare providers.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 2 Interventions

Intervention participants will complete two rounds of three virtual patient cases. In the first round, intervention participants will have access to standard of care diagnostic tools. They will then receive educational material about a novel AD assay. In the second round, they will automatically receive test results for the novel AD assay in addition to standard of care tools.

Group II: Control Active Control 1 Intervention

Control participants will complete two rounds of three virtual patient cases. In both rounds, control participants will have access to standard of care diagnostic tools. They will not receive the AD assay test results.

Who Is Running the Clinical Trial?

Qure Healthcare, LLC

Lead Sponsor

Trials

22

Recruited

4,000+

Beckman Coulter, Inc.

Industry Sponsor

Trials

39

Recruited

446,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12143641/

Alzheimer's disease blood-based biomarker testing Blood-based biomarker tests (BBMTs) for Alzheimer's disease (AD) provide value, but in the US, neither public nor private payers currently cover these tests.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2274580725002535

Disclosure of Alzheimer's disease blood-based biomarker ... Blood-based biomarkers (BBMs) for AD have emerged in recent years and represent the most promising diagnostic tool for AD at the population level [3]. Plasma ...

3. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.14203

Paving the way for Alzheimer's disease blood‐based ... Blood-based biomarkers (BBBMs) for Alzheimer's disease (AD) have the potential to revolutionize the detection and management of cognitive impairment.

4. fda.gov fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease

FDA Clears First Blood Test Used in Diagnosing ... The US Food and Drug Administration today cleared for marketing the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer's disease.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10688968/

Blood-based Biomarkers in Alzheimer's Disease: A Mini-review In a sample of 686 AD patients that underwent PET imaging with an amyloid tracer, the PrecivityAD™ test had a sensitivity of 92% and specificity of 77% in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12306682/

Alzheimer's Association Clinical Practice Guideline on ... When used appropriately, the panel judged the undesirable effects of BBM tests to be small; however, undesirable effects could be more ...

7. practicalneurology.com practicalneurology.com/diseases-diagnoses/alzheimer-disease-dementias/blood-based-biomarkers-in-alzheimer-disease-clinical-implementation-and-limitations/32100/?c4src=:sidebar

Blood-Based Biomarkers in Alzheimer Disease: Clinical Implem Although rare, complications ranging from mild headaches to CSF leaks and more severe adverse effects may occur.5 Amyloid and tau ligands ...

8. pro.alz.org pro.alz.org/hub/care-pathway/detection-and-diagnosis/blood-based-biomarkers-guideline

Clinical Practice Guideline: Blood-Based Biomarkers in ... Negative results rule out AD pathology; positive results need confirmation with amyloid PET or CSF AD biomarker analysis. Tests should meet >90% sensitivity and ...