Blood-based Biomarkers for Alzheimer's Disease at the Primary Care Level.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ptau217.
- Who it may be relevant to
- Registry conditions: Alzheimer's Disease (AD). Basic parameters: 55 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Diagnostic Validity and Clinical Impact of Blood-based Biomarkers for the Diagnosis of Alzheimer's Disease at the Primary Care Level.
Overview
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.
Interventions
- Diagnostic test ptau217
Quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human K2EDTA plasma.
Primary outcome measures
- Change in referral decision and working diagnosis [Time frame: 2 years]
- Cognitive decline [Time frame: 4 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Belgium · 1 center
- UZ Leuven/KU Leuven — Leuven
Identifiers
NCT: NCT07666113 · S71285 · PS-26-01-055975