Alzheimer Blood BiomarkersBRIDGE-AD2NCT07680335
The BRidge Towards Implementation of Blood-based Biomarkers to Enable Early and Accurate Diagnosis of Alzheimer's Disease
A study testing Plasma p-tau217 and neurofilament light chain results in people with Alzheimer Blood Biomarkers and Alzheimer's Disease (AD), run by Alzheimercentrum Amsterdam at 8 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer Blood Biomarkers, Alzheimer's Disease (AD)
- What is being tested?
- Plasma p-tau217 and neurofilament light chain results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 8 sitesNetherlands
- Study dates
- 17 Sep 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Netherlands8 sites, 8 recruiting
- Recruiting
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
A van Strien, MD PhD, 0031735532000
A van Strien, MD PhD
- Recruiting
Flevoziekenhuis
Almere Stad
M I Kester, MD PhD, 0031368688720, mkester@flevoziekenhuis.nl
M I Kester, MD PhD
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1081HV
F H Duits, MD PhD, 0031204440816, fduits@amsterdamumc.nl
F H Duits, MD PhD
- Recruiting
Spaarne Gasthuis
Haarlem
N SM Schoonenboom, MD PhD, 0031232240110, schoonenboom@spaarnegasthuis.nl
N SM Schoonenboom, MD PhD
- Recruiting
Tergooi MC
Hilversum
S S Staekenborg, MD PhD, 0031887531250, sstaekenborg@tergooi.nl
S S Staekenborg, MD PhD
- Recruiting
Frisius MC
Leeuwarden
N A Verwey, MD PhD, 0031582866666, niek.verwey@frisiusmc.nl
N A Verwey, MD PhD
- Recruiting
Dijklander Ziekenhuis
Purmerend
L AR Zwart, MD PhD, 0031299457142, l.a.r.zwart@dijklander.nl
L AR Zwart, MD PhD
- Not yet recruiting
Elisabeth-TweeSteden Ziekenhuis
Tilburg
H P Aben, MD PhD, 0031132210000, h.aben@etz.nl
H P Aben, MD PhD
About this study
Official title: The BRidge Towards Implementation of Blood-based Biomarkers to Enable Early and Accurate Diagnosis of Alzheimer's Disease (BRIDGE-AD2)
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.
- Being tested
- Plasma p-tau217 and neurofilament light chain results
- Keywords
- Randomised diagnostic trial
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma p-tau217 and neurofilament light chain resultsDiagnostic test
Results of the Quanterix Simoa ALZpath p-tau217 and Quanterix Simoa NfL assay.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Plasma p-tau217 and neurofilament light chain results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from baseline to final diagnosis
The time from baseline visit to final diagnosis will be reported in days.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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).
Measured: 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
Duration of patient follow-up (reported in days)
Measured: From enrolment to final diagnosis, assessed up to 100 months
Difference between the intervention group and the control group in patient management: referral
Referral to another specialist or center (yes/no)
Measured: 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
Prescription of medication (yes / no; if yes which medication)
Measured: From enrolment to final diagnosis, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start17 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Blood BiomarkersStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alzheimercentrum Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- Davos Alzheimer's Collaborative, Quanterix Corporation (in kind)
- Responsible party
- Principal investigator, Floor Duits, Alzheimercentrum Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680335
- Sponsor's protocol ID
- 2025.0070
- Other IDs
- 25-01-050817
- Acronym
- BRIDGE-AD2
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There are plans to share IPD through the ADDI platform, however a contract or data sharing agreement has not yet been established. Therefore it is not yet clear which specific IPD will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BRidge Towards Implementation of Blood-based Biomarkers to Enable Early and Accurate Diagnosis of Alzheimer's Disease (BRIDGE-AD2)
- ClinicalTrials.gov ID
- NCT07680335
- Acronym / sponsor ID
- BRIDGE-AD2 / 2025.0070
- Keywords
- Randomised diagnostic trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Alzheimercentrum AmsterdamUniversity, hospital or other
- Collaborators
- Davos Alzheimer's Collaborative, Quanterix Corporation (in kind)
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Diagnostic Test: Plasma p-tau217 and neurofilament light chain resultsIn addition to usual care and diagnostics, blood-based biomarker results are sent to the physician who can disclose the results to the patient |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma p-tau217 and neurofilament light chain resultsResults of the Quanterix Simoa ALZpath p-tau217 and Quanterix Simoa NfL assay. | Diagnostic test | Blood-based biomarker results are made available to the physician |
Primary outcome
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.
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.
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.
5 secondary outcomes
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: Undecided. There are plans to share IPD through the ADDI platform, however a contract or data sharing agreement has not yet been established. Therefore it is not yet clear which specific IPD will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma p-tau217 and neurofilament light chain results in people with Alzheimer Blood Biomarkers and Alzheimer's Disease (AD), run by Alzheimercentrum Amsterdam at 8 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Floor Duits, PhD (020 - 4440816, f.duits@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from baseline to final diagnosis (time frame: From enrolment to final diagnosis, assessed up to 100 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.