Alzheimer's Disease (AD)ADPriKNCT07666113
Blood-based Biomarkers for Alzheimer's Disease at the Primary Care Level.
A study testing ptau217 in people with Alzheimer's Disease (AD), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease (AD)
- What is being tested?
- ptau217
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteBelgium
- Study dates
- 26 May 2026to Apr 2038
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between 55 and 85 years old who consult their PCP due to concerns about their cognitive status.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven/KU Leuven
Leuven, 3000
Serafien D'hooge, MD, +32 16 33 86 31, serafien.dhooge@kuleuven.be
About this study
Official title: 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.
- Conditions
- Alzheimer's Disease (AD)
- Being tested
- ptau217
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ptau217Diagnostic test
Quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human K2EDTA plasma.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Other | All participants will get ptau217 measurements. Receives: Diagnostic Test: ptau217 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start26 May 2026
- Primary completionApr 2030 (estimated)
- Study completionApr 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease (AD)Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666113
- Sponsor's protocol ID
- S71285
- Other IDs
- PS-26-01-055975
- Acronym
- ADPriK
- Status last verified
- May 2026
- First submitted
- 12 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided