Alzheimer Disease (AD)NCT07099001
Establishing Clinical Utility Evidence for a Novel Alzheimer's Disease Blood-Based Biomarker Assay
A study testing Educational materials on the Alzheimer's disease assay and Alzheimer's disease assay results in people with Alzheimer Disease (AD) and Cognitive Decline, run by Qure Healthcare, LLC at 1 site in United States.
Trial summary
This is a national-level research study of neurologists and dementia specialists. The purpose of this study is to assess the clinical evaluation and management recommendations made by practicing providers for patient simulations with symptoms of cognitive decline. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease (AD), Cognitive Decline
- What is being tested?
- Educational materials on the Alzheimer's disease assay and Alzheimer's disease assay results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Board-certified in neurology for at least two years (and no more than 35 years
- Average at least 20 hours per week of clinical and patient care duties over the past six months
- Routinely evaluate patients at risk for Alzheimer's disease
- Practicing in the United States
- Able to read English
- Access to the internet
- Not participating in a clinical research study of the AD assay
- Informed, signed, and voluntarily consented to participate in this study
Who cannot join
- Board-certified in neurology for less than two years
- Board certification in neurology over 35 years ago
- Unable to read English
- Unable to access the internet
- Not practicing in the United States
- Not averaging at least 20 hours per week of clinical or patient care duties over the past six months
- Participating in a clinical research study of the AD assay
- Do not voluntarily consent to participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishing Clinical Utility Evidence for a Novel Alzheimer's Disease Blood-Based Biomarker Assay: A QURE Virtual Patient Randomized Controlled Trial
This is a national-level research study of neurologists and dementia specialists. The purpose of this study is to assess the clinical evaluation and management recommendations made by practicing providers for patient simulations with symptoms of cognitive decline.
Read the detailed description
QURE Healthcare will recruit a nationwide sample of neurologists and dementia specialists to assess the clinical evaluation and management potential of a novel diagnostic tool. The results of this study are expected to contribute to improved quality of care for patients with symptoms of Alzheimer's disease. Findings from this study will be submitted to a national journal for peer-reviewed publication. This study plans to enroll at least 150 healthcare providers.
This study will evaluate the clinical utility of Alzheimer's disease assay by analyzing improvement in the quality of physician decision-making regarding patients with symptoms of Alzheimer's disease, using a validated patient-simulation-based measurement approach, to achieve the following:
- Measure variation in clinical decisions among practicing neurologists, specifically in how they detect, measure, and manage Alzheimer's disease in patients with symptoms and/or risk factors of cognitive decline.
- Determine whether education on the Alzheimer's disease assay with accompanying test results leads to changes in clinical decision-making with regard to follow-up testing (e.g., CSF analysis, PET imaging), diagnostic accuracy, and treatment recommendations.
- Model whether the use of the Alzheimer's disease assay leads to higher-value and/or lower-cost care decisions (including follow-up testing, diagnostics, and treatment) that can lead to more efficient care.
- Determine whether the Alzheimer's disease assay results differentially impact treatment decisions for different patient types (use cases).
- Conditions
- Alzheimer Disease (AD), Cognitive Decline
- Being tested
- Educational materials on the Alzheimer's disease assay, Alzheimer's disease assay results
- Keywords
- Patient Simulation
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational materials on the Alzheimer's disease assayOther
Between Round 1 and Round 2 virtual patient case administration, Intervention participants will receive educational materials describing the clinical validation and use cases of the Alzheimer's disease assay. These materials will approximate the type of information physicians would receive to introduce them to the Alzheimer's disease assay and may be comprised of a slide deck, fact sheet, sample test report, and/or example case scenarios.
Alzheimer's disease assay resultsOther
Within each of their virtual patient cases in Round 2 of case administration, Intervention participants will receive Alzheimer's disease assay results at the clinically appropriate point for each case.
| Study group | Role | What they receive |
|---|---|---|
| Control | No 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. |
| Intervention | Experimental | 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. Receives: Other: Educational materials on the Alzheimer's disease assay; Other: Alzheimer's disease assay results |
What is being measured
The primary outcome is the main question the study is designed to answer.
QURE virtual patient clinical score difference
Difference-in-differences regression analysis between the control and the intervention groups' diagnosis and treatment of symptoms of cognitive decline, as measured by the participants' diagnostic and treatment case scores. In each QURE case, every participants' care recommendations are evaluated against evidence-based care scoring criteria, which can range from 0% to 100% (with higher percentages indicating better outcomes).
Measured: Up to 12 months
Change in follow-up decisions (QURE scored-based) after receiving AD assay results
Assessing changes in follow-up decisions (via QURE case domain scores) among intervention providers after they receive the results of the novel AD assay in the second round of case administration. In each QURE case, every participants' care recommendations are evaluated against evidence-based care scoring criteria, which can range from 0% to 100% (with higher percentages indicating better outcomes).
Measured: Up to 12 months
Secondary outcomes (2)
Variation in QURE virtual patient case baseline scores
Participants completing QURE virtual patients receive scores based upon the quality of care they provide. In each QURE case, every participants' care recommendations are evaluated against evidence-based care scoring criteria, which can range from 0% to 100% (with higher percentages indicating better outcomes). This measure will assess the baseline levels of variation in the care of virtual patients with symptoms of cognitive decline among all participants, including by use case types.
Measured: Up to 12 months
Difference in QURE virtual patient case scores by case type
Difference in the overall quality scores between control and intervention participants. The overall score is calculated as the percent of correct (evidence-based) minus incorrect (low-value) decisions divided by the total number of correct decisions in a QURE virtual patient case. Differences in scores between case types across rounds will be assessed to determine which use cases show the most improvement.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start8 Aug 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will enroll neurologists and dementia specialists practicing in the United States. Participants will be randomly assigned to either control or intervention arms upon enrollment. All eligible and consented participants will complete two rounds of three virtual patient simulations. The intervention arm participants will receive educational material about the novel Alzheimer's disease assay after round 1 of data collection. After a waiting period, intervention arm participants will receive the results of the AD assay at the appropriate point in the virtual patient simulation. Control arm participants will not receive results of the AD assay, but will have access to standard of care tools during both rounds of case administration.
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qure Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beckman Coulter, Inc.
- Responsible party
- Principal investigator, Trever Burgon, PhD, Qure Healthcare, LLC
- Investigators
- Trever Burgon, PhD, Principal investigator, QURE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099001
- Sponsor's protocol ID
- Pro00083791
- Status last verified
- Jan 2026
- First submitted
- 16 Jul 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Clinical Utility Evidence for a Novel Alzheimer's Disease Blood-Based Biomarker Assay: A QURE Virtual Patient Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07099001
- Acronym / sponsor ID
- Pro00083791
- Conditions
- Alzheimer Disease (AD), Cognitive Decline
- Keywords
- Patient Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Qure Healthcare, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Beckman Coulter, Inc.
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a national-level research study of neurologists and dementia specialists. The purpose of this study is to assess the clinical evaluation and management recommendations made by practicing providers for patient simulations with symptoms of cognitive decline.
Detailed description
QURE Healthcare will recruit a nationwide sample of neurologists and dementia specialists to assess the clinical evaluation and management potential of a novel diagnostic tool. The results of this study are expected to contribute to improved quality of care for patients with symptoms of Alzheimer's disease. Findings from this study will be submitted to a national journal for peer-reviewed publication. This study plans to enroll at least 150 healthcare providers.
This study will evaluate the clinical utility of Alzheimer's disease assay by analyzing improvement in the quality of physician decision-making regarding patients with symptoms of Alzheimer's disease, using a validated patient-simulation-based measurement approach, to achieve the following:
- Measure variation in clinical decisions among practicing neurologists, specifically in how they detect, measure, and manage Alzheimer's disease in patients with symptoms and/or risk factors of cognitive decline.
- Determine whether education on the Alzheimer's disease assay with accompanying test results leads to changes in clinical decision-making with regard to follow-up testing (e.g., CSF analysis, PET imaging), diagnostic accuracy, and treatment recommendations.
- Model whether the use of the Alzheimer's disease assay leads to higher-value and/or lower-cost care decisions (including follow-up testing, diagnostics, and treatment) that can lead to more efficient care.
- Determine whether the Alzheimer's disease assay results differentially impact treatment decisions for different patient types (use cases).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will enroll neurologists and dementia specialists practicing in the United States. Participants will be randomly assigned to either control or intervention arms upon enrollment. All eligible and consented participants will complete two rounds of three virtual patient simulations. The intervention arm participants will receive educational material about the novel Alzheimer's disease assay after round 1 of data collection. After a waiting period, intervention arm participants will receive the results of the AD assay at the appropriate point in the virtual patient simulation. Control arm participants will not receive results of the AD assay, but will have access to standard of care tools during both rounds of case administration.
| Arm | Type | Receives |
|---|---|---|
| Control | No 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. |
| Intervention | Experimental | Other: Educational materials on the Alzheimer's disease assay, Other: Alzheimer's disease assay resultsIntervention 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Board-certified in neurology for at least two years (and no more than 35 years
- Average at least 20 hours per week of clinical and patient care duties over the past six months
- Routinely evaluate patients at risk for Alzheimer's disease
- Practicing in the United States
- Able to read English
Key exclusion criteria (8 listed)
- Board-certified in neurology for less than two years
- Board certification in neurology over 35 years ago
- Unable to read English
- Unable to access the internet
- Not practicing in the United States
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational materials on the Alzheimer's disease assayBetween Round 1 and Round 2 virtual patient case administration, Intervention participants will receive educational materials describing the clinical validation and use cases of the Alzheimer's disease assay. These materials will approximate the type of information physicians would receive to introduce them to the Alzheimer's disease assay and may be comprised of a slide deck, fact sheet, sample test report, and/or example case scenarios. | Other | Intervention |
| Alzheimer's disease assay resultsWithin each of their virtual patient cases in Round 2 of case administration, Intervention participants will receive Alzheimer's disease assay results at the clinically appropriate point for each case. | Other | Intervention |
Primary outcome
QURE virtual patient clinical score difference
Time frame: Up to 12 months
Difference-in-differences regression analysis between the control and the intervention groups' diagnosis and treatment of symptoms of cognitive decline, as measured by the participants' diagnostic and treatment case scores. In each QURE case, every participants' care recommendations are evaluated against evidence-based care scoring criteria, which can range from 0% to 100% (with higher percentages indicating better outcomes).
Change in follow-up decisions (QURE scored-based) after receiving AD assay results
Time frame: Up to 12 months
Assessing changes in follow-up decisions (via QURE case domain scores) among intervention providers after they receive the results of the novel AD assay in the second round of case administration. In each QURE case, every participants' care recommendations are evaluated against evidence-based care scoring criteria, which can range from 0% to 100% (with higher percentages indicating better outcomes).
2 secondary outcomes
Variation in QURE virtual patient case baseline scores
Time frame: Up to 12 months
Difference in QURE virtual patient case scores by case type
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Disease (AD)
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Active, not recruitingPhase 2
A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)
Alzheimer's Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trever Burgon, PhD principal investigator
QURE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational materials on the Alzheimer's disease assay and Alzheimer's disease assay results in people with Alzheimer Disease (AD) and Cognitive Decline, run by Qure Healthcare, LLC at 1 site 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 8 inclusion and 8 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 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
QURE virtual patient clinical score difference (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2026.