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RecruitingNCT07666113ADPriKUpdated Jun 24, 2026

Blood-based Biomarkers for Alzheimer's Disease at the Primary Care Level.

An interventional study of ptau217 in Alzheimer's Disease (AD), sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 55 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started May 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Not applicable
Ages
55 Years to 85 Years
Sex
All
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Study summary

The goal of this study is to determine how blood biomarker tests (ptau217 and ptau217/Aβ42) performed in primary care influence the patient trajectory in individuals with cognitive concerns.

Participants will provide a blood sample for biomarker testing and undergo clinical assessments as part of diagnostic evaluation.

02

Conditions studied

  • Alzheimer's Disease (AD)

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 240 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients between 55 and 85 years old who consult their PCP due to concerns about their cognitive status.

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
240 participants (estimated)

Study arms

  • Other
    All participants

    All participants will get ptau217 measurements.

    Diagnostic Test: ptau217

Interventions

  • Diagnostic testptau217

    Quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human K2EDTA plasma.

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What researchers measure

Primary outcomes

  1. Change in referral decision and working diagnosis

    Change in working diagnosis and referral decision (n = 240): The % of cases where a change occurs will be calculated from the contingency matrix.

    Time frame: 2 years

  2. Cognitive decline

    Positive (PPV) and negative (NPV) predictive value, the positive (LR+) and negative (LR-) likelihood ratio for predicting cognitive decline in the subsequent four years.

    Time frame: 4 years

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07666113
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
Jun 24, 2026
Start date
May 26, 2026
Primary completion
Apr 2030 (estimated)
Completion
Apr 2038 (estimated)
Last update
Jun 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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