Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07680335

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Alzheimer Blood Biomarkers Alzheimer Disease Alzheimer's Disease (AD) Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC, Amsterdam, North Holland, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Plasma p-tau217 and neurofilament light chain results

Diagnostic Test

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

Primary outcomes

  1. Time from baseline to final diagnosis

    Time frame: From enrolment to final diagnosis, assessed up to 100 months

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

  2. Change in diagnosis

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

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

  3. Change in physician's confidence in diagnosis

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

    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.

Secondary outcomes

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

    Time frame: From enrolment to final diagnosis, assessed up to 100 months

    Use of ancillary tests (yes/no), including neuropsychological evaluation, brain CT, brain MRI, CSF biomarker analysis, amyloid PET, FDG PET, DaT-SPECT, EEG/MEG, genetic testing, and speech therapy consultation. If performed, the timing in days from enrollment will be reported.

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

    Time frame: From enrolment to final diagnosis, assessed up to 100 months

    Concordance will be defined as the percentage of BBM results (positive or negative) that is concordant with CSF or amyloid PET results (positive or negative).

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

    Time frame: From enrolment to final diagnosis, assessed up to 100 months

    Duration of patient follow-up (reported in days)

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

    Time frame: From enrolment to final diagnosis, assessed up to 100 months

    Referral to another specialist or center (yes/no)

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

    Time frame: From enrolment to final diagnosis, assessed up to 100 months

    Prescription of medication (yes / no; if yes which medication)

Other outcomes

  1. Usefulness of AD BBMs per case as perceived by the physician

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

    In the intervention group: Usefulness as perceived by the physician measured on a 5-point Likert scale with 1 being extremely unuseful and 5 being extremely useful.

    In the control group: Hypothetical usefulness (yes/no/maybe) as perceived by the physician in case the BBM results would have been received.

    In all cases: Desireability of the blood test being performed (yes/no) as perceived by the physician prior to receiving BBM results.

  2. Patients' motivation for participation

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

    Participants will be asked to indicate their motivation for participation.

  3. Patients' experience with receiving or not receiving BBM results

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

    Intervention group: Experience of receiving BBM results will be assessed by asking participants:

    • Whether not receiving the results would have been preferred (yes/no/I do not know)
    • Whether receiving the results had positive consequences (yes/no)
    • Whether receiving the results had negative consequences (yes/no)

    In the control group: experience of not receiving BBM results will be assessed by asking participants:

    • Whether receiving the results would have been preferred (yes/no/I do not know)

  4. Patient's understanding of the BBM results

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

    Participant's understanding will be assessed by asking participants whether the diagnosis changed after receiving BBM results. If yes, participants will be asked to indicate the initial diagnosis. Additionally, participants will be asked to explain, in their own words, what the BBM results meant.

  5. Patients' satisfaction with the provision of information

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

    In case the results were disclosed to the patient: Satisfaction will be assessed by rating their agreement with 2 statements on a 5-point agree/disagree scale with 1 being strongly disagree and 5 being strongly agree.

  6. Patients' satisfaction with the decision to participate

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

    In all cases: Satisfaction will be assessed by asking participants to rate their agreement with 4 statements on a 5-point decision regret scale with 1 being strongly disagree and 5 being strongly agree.

  7. Cognitive performance measured by the MOCA

    Time frame: From enrolment to final diagnosis, assessed up to 100 months

    Total scores of the Montreal Cognitive Assessment (MoCA) will be registered, if performed during clinical work-up. Scores range from 0 to 30.

  8. Cognitive performance measured by the MMSE

    Time frame: From enrolment to final diagnosis, assessed up to 100 months

    Total scores of the Mini-Mental State Examination (MMSE) will be registered, if performed during clinical work-up. Scores range from 0 to 30.

  9. Survival

    Time frame: Up to 10 years after study completion

    Information on survival will be requested from Statistics Netherlands (Centraal Bureau voor de Statistiek; CBS), provided informed consent has been given for this (optional / separate question in ICF).

Study contacts

Contact information is provided by the study sponsor or research team.

Floor Duits, PhD

CONTACT

[email protected]

020 - 4440816

Sponsors and collaborators

Lead sponsor

Alzheimercentrum Amsterdam

Other

Collaborators

  • Davos Alzheimer's Collaborative
  • Quanterix Corporation (in kind)

Registry information

Official study title

The BRidge Towards Implementation of Blood-based Biomarkers to Enable Early and Accurate Diagnosis of Alzheimer's Disease (BRIDGE-AD2)

Acronym: BRIDGE-AD2

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.