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

June 17, 2026 updated by: Universitaire Ziekenhuizen KU Leuven

The Diagnostic Validity and Clinical Impact of Blood-based Biomarkers for the Diagnosis of Alzheimer's Disease at the Primary Care Level.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: All participants
All participants will get ptau217 measurements.
Diagnostic test: ptau217
Quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human K2EDTA plasma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in referral decision and working diagnosis
Time Frame: 2 years
Change in working diagnosis and referral decision (n = 240): The % of cases where a change occurs will be calculated from the contingency matrix.
2 years
Cognitive decline
Time Frame: 4 years
Positive (PPV) and negative (NPV) predictive value, the positive (LR+) and negative (LR-) likelihood ratio for predicting cognitive decline in the subsequent four years.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2026

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2038

Study Registration Dates

First Submitted

June 12, 2026

First Submitted That Met QC Criteria

June 17, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S71285
  • PS-26-01-055975 (Other Identifier: Eudamed number - FAMHP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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