Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07666113

Blood-based Biomarkers for 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Alzheimer's Disease (AD) Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ptau217

Diagnostic Test

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

Primary outcomes

  1. 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. 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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: ADPriK

Important dates

Study start
2026
Primary completion
2030
Study completion
2038
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.