NCT07666113

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
142mo left

Started May 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026Apr 2038

Study Start

First participant enrolled

May 26, 2026

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2030

Expected
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2038

Last Updated

June 24, 2026

Status Verified

May 1, 2026

Enrollment Period

3.9 years

First QC Date

June 12, 2026

Last Update Submit

June 17, 2026

Conditions

Alzheimer's Disease (AD)

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

All participants

OTHER

All participants will get ptau217 measurements.

Diagnostic Test: ptau217

Interventions

ptau217DIAGNOSTIC_TEST

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

All participants

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between 55 and 85 years old who consult their PCP due to concerns about their cognitive status.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven/KU Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2026

First Posted

June 24, 2026

Study Start

May 26, 2026

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2038

Last Updated

June 24, 2026

Record last verified: 2026-05

Locations

BE(1)