Blood-based biomarkers for Alzheimer’s disease in primary care
Official title: The Diagnostic Validity and Clinical Impact of Blood-based Biomarkers for the Diagnosis of Alzheimer's Disease at the Primary Care Level.
Run by Universitaire Ziekenhuizen KU Leuven · NCT07666113 · Data updated 2026-11-12
This study tests whether a blood test for ps-tau217 and the ps-tau217/Aβ42 ratio can help primary care patients with cognitive concerns understand their situation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 55 Years to 85 Years |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Status | Recruiting |
| Started | May 26, 2026 |
| Main results expected | April 2030 |
| Study ends | April 2038 |
| Registry record updated | June 24, 2026 |
| Trial ID | NCT07666113 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 55–85 who present to their PCP with concerns about cognitive function and are able to participate in diagnostic workups.
✕Probably not a fit
Patients with cognitive concerns not related to underlying biomarker changes or with comorbidities that affect testing may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study uses a blood biomarker test to see how ptau217 and ptau217/Aβ42 results influence diagnostic pathways for adults aged 55–85 who visit their PCP with cognitive concerns. Participants provide a blood sample and complete standard clinical assessments as part of their diagnostic workup. The goal is to see if these biomarkers can inform decisions and trajectories in the care of potential Alzheimer’s disease. The study is conducted at KU Leuven and UZ Leuven in Leuven, Belgium, under the lead sponsor Universitaire Ziekenhuizen KU Leuven.
Why it matters
Potential benefit: If successful, the biomarkers could help PCPs triage and tailor diagnostic and management plans for patients with cognitive concerns.
How similar studies have gone: Biomarker approaches in Alzheimer’s diagnostics have shown promise in other settings, but primary-care–level application remains an area of active investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients between 55 and 85 years old who consult their PCP due to concerns about their cognitive status. Exclusion Criteria: * Comorbidities that would interfere with study cooperation or interpretability of study results (for instance substance abuse or cardiac, renal or hepatic failure). * Concomitant medications that would interfere with cognitive assessments. * A prior diagnosis of AD and related disorders or other neurodegenerative disease.
Where it's running
-
UZ Leuven/KU Leuven
Leuven, Belgium Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.