The BRidge Towards Implementation of Blood-based Biomarkers to Enable Early and Accurate Diagnosis of Alzheimer's Disease

NCT07680335 | Recruiting

• 2 other identifiers: 2025.007025-01-050817
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 8

Brief Summary

Cognitive disorders have a broad differential diagnosis, and a precise, timely diagnosis is essential for personalized treatment and care. Currently, dementia diagnoses are often not further specified according to the underlying pathology and are frequently delayed by several years. However, with the upcoming disease-modifying treatments (DMTs) for AD, an accurate, pathology-driven (i.e., etiological) diagnosis will become necessary. Blood-based biomarkers (BBMs) are promising tools for detecting Alzheimer's disease (AD), with current research showing high concordance with cerebrospinal fluid (CSF) biomarkers and amyloid PET imaging. However, it remains unclear how physicians would value the availability of BBMs for AD in routine clinical practice. The investigators hypothesize that BBMs will benefit both patients and physicians in the diagnostic process within a memory clinic setting. This study aims to investigate clinical impact and diagnostic utility of blood-based biomarkers for AD in the diagnostic process of a memory clinic. The main objectives are to investigate change in diagnosis, diagnostic certainty and patient management, due to BBM results.

Conditions

Alzheimer Blood Biomarkers; Alzheimer's Disease (AD)

Keywords

Randomised diagnostic trial

Outcome Measures

Primary Outcomes (3)

• Time from baseline to final diagnosis

  The time from baseline visit to final diagnosis will be reported in days.

  From enrolment to final diagnosis, assessed up to 100 months

• Change in diagnosis

  Comparison between the diagnosis (syndrome diagnosis and etiology) before and after BBM testing. Change in diagnosis will be reported as yes/no.

  From enrolment to when BBM test results have been disclosed to the physician, assessed up to 3 months

• Change in physician's confidence in diagnosis

  Comparison between physician's confidence in diagnosis before and after BBM testing within the intervention group. Physician's confidence will be measured on a 7-point Likert scale, with 1 being very uncertain and 7 being very certain.

  From enrolment to when BBM test results have been disclosed to the physician, assessed up to 3 months

Secondary Outcomes (5)

• Difference between the intervention group and the control group in use and timing of ancillary tests

  From enrolment to final diagnosis, assessed up to 100 months

• Concordance of BBM results with the presence of AD pathology according to CSF or amyloid PET

  From enrolment to final diagnosis, assessed up to 100 months

• Difference between the intervention group and the control group in patient management: follow-up duration

  From enrolment to final diagnosis, assessed up to 100 months

• Difference between the intervention group and the control group in patient management: referral

  From enrolment to final diagnosis, assessed up to 100 months

• Difference between the intervention group and the control group in patient management: prescription of medication

  From enrolment to final diagnosis, assessed up to 100 months

Other Outcomes (9)

• Usefulness of AD BBMs per case as perceived by the physician

  From enrolment to when BBM test results have been disclosed to the physician, assessed up to 3 months

• Patients' motivation for participation

  After the blood test is performed, assessed up to 3 months

• Patients' experience with receiving or not receiving BBM results

  After the blood test is performed, assessed up to 3 months

Study Arms (2)

Usual care path

NO INTERVENTION

Blood-based biomarker results are not disclosed to the physician and/or patient, patient receives usual care and diagnostics

Blood-based biomarker results are made available to the physician

EXPERIMENTAL

In addition to usual care and diagnostics, blood-based biomarker results are sent to the physician who can disclose the results to the patient

Diagnostic Test: Plasma p-tau217 and neurofilament light chain results

Interventions

Plasma p-tau217 and neurofilament light chain results DIAGNOSTIC_TEST

Results of the Quanterix Simoa ALZpath p-tau217 and Quanterix Simoa NfL assay.

Blood-based biomarker results are made available to the physician

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient presents in memory clinic with cognitive complaints.
• The physician is concerned about underlying AD as etiology of the complaints.
• Adequate fluency in Dutch to understand informed consent procedure.

You may not qualify if:

• Age under 55.
• Previous biomarker-confirmed diagnosis of AD.
• Alcohol or drug abuse to such an extent that treatment would be advisable.
• Patient is incapacitated, and is not able to judge consequences of participation.

Sponsors & Collaborators

• Alzheimercentrum Amsterdam: lead
• Davos Alzheimer's Collaborative: collaborator
• Quanterix Corporation (in kind): collaborator

Study Sites (8)

Amsterdam UMC

Amsterdam, North Holland, 1081HV, Netherlands

RECRUITING

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

RECRUITING

Flevoziekenhuis

Almere Stad, Netherlands

RECRUITING

Spaarne Gasthuis

Haarlem, Netherlands

RECRUITING

Tergooi MC

Hilversum, Netherlands

RECRUITING

Frisius MC

Leeuwarden, Netherlands

RECRUITING

Dijklander Ziekenhuis

Purmerend, Netherlands

RECRUITING

Elisabeth-TweeSteden Ziekenhuis

Tilburg, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Floor Duits, PhD

CONTACT

020 - 4440816; f.duits@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: July 2, 2026
• Study Start: September 17, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Locations

NL (8)