Blood-based Biomarkers for Alzheimer's Disease at the Pri... | NCT07666113

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

NCT07666113

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Recruiting

Last Update Posted

Jun 24, 2026Actual

Enrollment

240Estimated

Phase

Not Applicable

Conditions

Alzheimer's Disease (AD)

Interventions

ptau217

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PS-26-01-055975	Other Identifier	Eudamed number - FAMHP

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 26, 2026Actual

Primary Completion Date

Apr 2030Estimated

Completion Date

Apr 2038Estimated

First Submitted Date

Jun 12, 2026

First Submission Date that Met QC Criteria

Jun 17, 2026

First Posted Date

Jun 24, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2026

Last Update Posted Date

Jun 24, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All participants	Other	All participants will get ptau217 measurements.	Diagnostic Test: ptau217

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ptau217	Diagnostic Test	Quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human K2EDTA plasma.	All participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	4 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven/KU Leuven	Recruiting	Leuven		3000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided