Alzheimer DiseaseALZANNCT05427448
Validation of Blood Biomarkers for Alzheimer's Disease
A study testing Measurement of amyloid and pTau blood biomarkers in people with Alzheimer Disease and Mild Cognitive Impairment, run by University Hospital, Montpellier at 3 sites in France.
Trial summary
Alzheimer's disease (AD) has gradually become one of the major global public health issues due to its prevalence, which increases with age and life expectancy, and the economic cost of caring for patients whose cognitive decline progressively leads to loss of functional autonomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment, Dementia
- What is being tested?
- Measurement of amyloid and pTau blood biomarkers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 3 sitesFrance
- Study dates
- 24 Nov 2022to 20 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients consulting in memory clinics from Montpellier, Nîmes, or Perpignan.
- Age >= 18 years old
- CSF AD biomarkers performed for diagnostic purpose in clinical routine practice
- Having given their written and enlightened consent
- Affiliated or beneficiary of the national health insurance
Who cannot join
- Contraindication or refusal of lumbar puncture
- Patient deprived of freedom, by court or administrative order, or major protected by law
- Pregnant or breastfeeding women
Trial locations and contacts
3 sites in 1 country.
France3 sites
Montpellier University Hospital
Montpellier, Occitanie, 34000
Nîmes University Hospital
Nîmes, Occitanie, 30000
Perpignan Regional Hospital
Perpignan, Occitanie, 66000
About this study
Official title: Clinical Validation of the Use of Blood Biomarkers for the Diagnosis and Monitoring of Alzheimer's Disease
Alzheimer's disease (AD) has gradually become one of the major global public health issues due to its prevalence, which increases with age and life expectancy, and the economic cost of caring for patients whose cognitive decline progressively leads to loss of functional autonomy.
The diagnosis of AD is based on a multidisciplinary approach, involving, among other things, evaluation of the medical history together with clinical symptoms and signs, neuropsychological tests and neuroimaging. The quantification of cerebrospinal fluid (CSF) core biomarkers (amyloid beta peptides [Ab1-40 and Ab1-42], total tau [t-tau] and its phosphorylated form on threonine 181 [p-tau(181)]) has progressively proven utility for the diagnosis of AD and its prodromal forms. CSF biomarkers are now included in international guidelines for the diagnosis of AD in research settings and clinical practice and the Alzheimer's Association appropriate use criteria for the use of lumbar puncture and CSF testing in the diagnosis of AD have been published. Such biochemical diagnostics are currently implemented in many specialized centers around the world.
Read more
Recent progress in the biological diagnosis of AD is considerable, with the possibility, thanks to ultra-sensitive tests realized notably with the SIMOA technology, of having Ab1-40, Ab1-42, t-tau and p-tau(181) also detectable in the blood using commercial kits. The performance for AD detection has been evaluated by many groups including on retrospective samples.
It is now essential to evaluate the interest of blood-based biomarkers of AD, prospectively and in real life condition to confront them with pre-analytical and analytical variabilities. It is also important to position them in relation to CSF analysis and AD management, from risk assessment, diagnosis, to therapeutic strategies.
Read the detailed description
Rationale of the project:
Recent progress in the biological diagnosis of Alzheimer's disease (AD) is considerable, with the possibility, thanks in particular to ultra-sensitive tests, of having relevant blood biomarkers. These biomarkers, mainly represented by amyloid peptides, tau proteins and neurofilaments, make it possible to consider a stratification of patients according to different classifications, including the ATN scale. Their diagnostic value has been mainly tested on retrospective samples and it is now essential to use them prospectively to confront them with pre-analytical and analytical variability. It is also important to position them in relation to CSF analysis and AD management, from risk assessment, diagnosis, to therapeutic strategies.
Main objective:
To evaluate, in a prospective consecutive enrollment clinical trial, the diagnostic performance (sensitivity, specificity) of blood biomarkers for Alzheimer's disease.
Secondary objectives:
- Interest of blood biomarkers for detection of normal/pathological CSF profiles.
- Interest of blood biomarkers for other disease including, amyloid angiopathy, frontotemporal dementia (FTD) or lewy body disease (LBD).
Methodology:
The investigator's laboratory daily receives CSF samples from regional "memory clinics" (mainly from Montpellier, Nîmes, Perpignan) for Aß40, Aß42, t-Tau and p-Tau(181) assays. The results of these tests performed weekly on an automated platform are used by neurologists for the diagnosis of AD. In this non-interventional multi-center clinical trial, with the informed consent of patients, one tube of plasma in addition to CSF is collected. In parallel with the CSF, amyloid peptides and plasma p-Tau is measured. The ApoE4 status will also be determined using MS as previously published by the investigator's group. Plasma biomarkers will then be combined to confirm the presence of AD, as has already been done on retrospective samples by the investigator's laboratory and others. Considering a disease prevalence rate of 20% in the screened population, and to reach a sensitivity of 80% and a specificity close to 90%, it is necessary to include a total of 311 patients in order to obtain an estimate of sensitivity and specificity with a 95% accuracy of +/- 10%. The lost to follow-up rate of about 10% requires the enrollment of 342 patients. The diagnostic performance of this profile will be compared to that of CSF, as well as to the diagnosis assessed by a multidisciplinary team one year after sampling.
Expected benefit:
The confirmation that blood biomarkers of AD achieve satisfactory diagnostic performance in a clinical setting allows them to be considered in routine use, as a less invasive method, thus with greater acceptance and also the possibility of longitudinal use. The benefit also lies in the evaluation of the interest of supplemental biomarkers such as NfL, for related diseases.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Dementia, Tauopathies
- Being tested
- Measurement of amyloid and pTau blood biomarkers
- Keywords
- blood, Alzheimer, biomarker
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia, Tauopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of amyloid and pTau blood biomarkersDiagnostic test
Detection of plasma Amyloid beta 1-40 and 1-42 peptide and phosphorylated tau isoforms.
| Study group | Role | What they receive |
|---|---|---|
| Prospective multisite clinical trial with consecutive recruitment. | Experimental | Patients consulting in memory clinics from Montpellier, Nîmes, or Perpignan. CSF AD biomarkers performed for diagnostic purpose in clinical routine practice Receives: Diagnostic Test: Measurement of amyloid and pTau blood biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of blood biomarkers for Alzheimer's disease
Calculate the performance (sensitivity, specificity) of biomarkers, alone or in combination, for the detection of Alzheimer's disease as defined by the McKhann criteria.
Measured: 24 months
Secondary outcomes (2)
Prediction of CSF profile
Calculate the performance (sensitivity, specificity) of biomarkers, alone or in combination, for the detection of normal vs pathological CSF profile (ATN)
Measured: 24 months
Diagnostic performance of blood biomarkers for FTD or LBD
Calculate the performance (sensitivity, specificity) of biomarkers, alone or in combination.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start24 Nov 2022
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective consecutive enrollment clinical trial to assess the diagnostic performance (sensitivity, specificity) of blood biomarkers for Alzheimer's disease.
- Masking
- None (open label)
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain Lehmann, MD PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427448
- Sponsor's protocol ID
- RECHMPL21_0586
- Acronym
- ALZAN
- Status last verified
- Dec 2025
- First submitted
- 17 Jun 2022
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Delaby C, Alcolea D, Hirtz C, Vialaret J, Kindermans J, Morichon L, Fortea J, Belbin O, Gabelle A, Blennow K, Zetterberg H, Lleo A, Lehmann S. Blood amyloid and tau biomarkers as predictors of cerebrospinal fluid profiles. J Neural Transm (Vienna). 2022 Feb;129(2):231-237. doi: 10.1007/s00702-022-02474-9. Epub 2022 Feb 15.
PubMed 35169889Lleo A, Zetterberg H, Pegueroles J, Karikari TK, Carmona-Iragui M, Ashton NJ, Montal V, Barroeta I, Lantero-Rodriguez J, Videla L, Altuna M, Benejam B, Fernandez S, Valldeneu S, Garzon D, Bejanin A, Iulita MF, Camacho V, Medrano-Martorell S, Belbin O, Clarimon J, Lehmann S, Alcolea D, Blesa R, Blennow K, Fortea J. Phosphorylated tau181 in plasma as a potential biomarker for Alzheimer's disease in adults with Down syndrome. Nat Commun. 2021 Jul 14;12(1):4304. doi: 10.1038/s41467-021-24319-x.
PubMed 34262030Alcolea D, Delaby C, Munoz L, Torres S, Estelles T, Zhu N, Barroeta I, Carmona-Iragui M, Illan-Gala I, Santos-Santos MA, Altuna M, Sala I, Sanchez-Saudinos MB, Videla L, Valldeneu S, Subirana A, Pegueroles J, Hirtz C, Vialaret J, Lehmann S, Karikari TK, Ashton NJ, Blennow K, Zetterberg H, Belbin O, Blesa R, Clarimon J, Fortea J, Lleo A. Use of plasma biomarkers for AT(N) classification of neurodegenerative dementias. J Neurol Neurosurg Psychiatry. 2021 Nov;92(11):1206-1214. doi: 10.1136/jnnp-2021-326603. Epub 2021 Jun 8.
PubMed 34103344Mondesert E, Cristol JP, Bargnoux AS, Duchiron M, Busto GU, Hirtz C, Barnier-Figue G, Perrein F, Turpinat C, Jurici S, Gabelle A, Bennys K, Lehmann S, Delaby C. Influence of Decreased Kidney Function on Plasma Biomarkers of Neurodegenerative Disorders in Routine Care: Confirmation of the Interest of Ratios. Neurology. 2026 May 12;106(9):e214931. doi: 10.1212/WNL.0000000000214931. Epub 2026 Apr 14.
PubMed 41980230
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the Use of Blood Biomarkers for the Diagnosis and Monitoring of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05427448
- Acronym / sponsor ID
- ALZAN / RECHMPL21_0586
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Dementia, Tauopathies
- Keywords
- blood, Alzheimer, biomarker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 22 Jun 2022 (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.
Alzheimer's disease (AD) has gradually become one of the major global public health issues due to its prevalence, which increases with age and life expectancy, and the economic cost of caring for patients whose cognitive decline progressively leads to loss of functional autonomy.
The diagnosis of AD is based on a multidisciplinary approach, involving, among other things, evaluation of the medical history together with clinical symptoms and signs, neuropsychological tests and neuroimaging. The quantification of cerebrospinal fluid (CSF) core biomarkers (amyloid beta peptides [Ab1-40 and Ab1-42], total tau [t-tau] and its phosphorylated form on threonine 181 [p-tau(181)]) has progressively proven utility for the diagnosis of AD and its prodromal forms. CSF biomarkers are now included in international guidelines for the diagnosis of AD in research settings and clinical practice and the Alzheimer's Association appropriate use criteria for the use of lumbar puncture and CSF testing in the diagnosis of AD have been published. Such biochemical diagnostics are currently implemented in many specialized centers around the world.
Recent progress in the biological diagnosis of AD is considerable, with the possibility, thanks to ultra-sensitive tests realized notably with the SIMOA technology, of having Ab1-40, Ab1-42, t-tau and p-tau(181) also detectable in the blood using commercial kits. The performance for AD detection has been evaluated by many groups including on retrospective samples.
It is now essential to evaluate the interest of blood-based biomarkers of AD, prospectively and in real life condition to confront them with pre-analytical and analytical variabilities. It is also important to position them in relation to CSF analysis and AD management, from risk assessment, diagnosis, to therapeutic strategies.
Detailed description
Rationale of the project:
Recent progress in the biological diagnosis of Alzheimer's disease (AD) is considerable, with the possibility, thanks in particular to ultra-sensitive tests, of having relevant blood biomarkers. These biomarkers, mainly represented by amyloid peptides, tau proteins and neurofilaments, make it possible to consider a stratification of patients according to different classifications, including the ATN scale. Their diagnostic value has been mainly tested on retrospective samples and it is now essential to use them prospectively to confront them with pre-analytical and analytical variability. It is also important to position them in relation to CSF analysis and AD management, from risk assessment, diagnosis, to therapeutic strategies.
Main objective:
To evaluate, in a prospective consecutive enrollment clinical trial, the diagnostic performance (sensitivity, specificity) of blood biomarkers for Alzheimer's disease.
Secondary objectives:
- Interest of blood biomarkers for detection of normal/pathological CSF profiles.
- Interest of blood biomarkers for other disease including, amyloid angiopathy, frontotemporal dementia (FTD) or lewy body disease (LBD).
Methodology:
The investigator's laboratory daily receives CSF samples from regional "memory clinics" (mainly from Montpellier, Nîmes, Perpignan) for Aß40, Aß42, t-Tau and p-Tau(181) assays. The results of these tests performed weekly on an automated platform are used by neurologists for the diagnosis of AD. In this non-interventional multi-center clinical trial, with the informed consent of patients, one tube of plasma in addition to CSF is collected. In parallel with the CSF, amyloid peptides and plasma p-Tau is measured. The ApoE4 status will also be determined using MS as previously published by the investigator's group. Plasma biomarkers will then be combined to confirm the presence of AD, as has already been done on retrospective samples by the investigator's laboratory and others. Considering a disease prevalence rate of 20% in the screened population, and to reach a sensitivity of 80% and a specificity close to 90%, it is necessary to include a total of 311 patients in order to obtain an estimate of sensitivity and specificity with a 95% accuracy of +/- 10%. The lost to follow-up rate of about 10% requires the enrollment of 342 patients. The diagnostic performance of this profile will be compared to that of CSF, as well as to the diagnosis assessed by a multidisciplinary team one year after sampling.
Expected benefit:
The confirmation that blood biomarkers of AD achieve satisfactory diagnostic performance in a clinical setting allows them to be considered in routine use, as a less invasive method, thus with greater acceptance and also the possibility of longitudinal use. The benefit also lies in the evaluation of the interest of supplemental biomarkers such as NfL, for related diseases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective consecutive enrollment clinical trial to assess the diagnostic performance (sensitivity, specificity) of blood biomarkers for Alzheimer's disease.
| Arm | Type | Receives |
|---|---|---|
| Prospective multisite clinical trial with consecutive recruitment. | Experimental | Diagnostic Test: Measurement of amyloid and pTau blood biomarkersPatients consulting in memory clinics from Montpellier, Nîmes, or Perpignan. CSF AD biomarkers performed for diagnostic purpose in clinical routine practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients consulting in memory clinics from Montpellier, Nîmes, or Perpignan.
- Age >= 18 years old
- CSF AD biomarkers performed for diagnostic purpose in clinical routine practice
- Having given their written and enlightened consent
- Affiliated or beneficiary of the national health insurance
Key exclusion criteria (3 listed)
- Contraindication or refusal of lumbar puncture
- Patient deprived of freedom, by court or administrative order, or major protected by law
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Measurement of amyloid and pTau blood biomarkersDetection of plasma Amyloid beta 1-40 and 1-42 peptide and phosphorylated tau isoforms. | Diagnostic test | Prospective multisite clinical trial with consecutive recruitment. |
Primary outcome
Diagnostic performance of blood biomarkers for Alzheimer's disease
Time frame: 24 months
Calculate the performance (sensitivity, specificity) of biomarkers, alone or in combination, for the detection of Alzheimer's disease as defined by the McKhann criteria.
2 secondary outcomes
Prediction of CSF profile
Time frame: 24 months
Diagnostic performance of blood biomarkers for FTD or LBD
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Results publication: PubMed 35169889Delaby C, Alcolea D, Hirtz C, Vialaret J, Kindermans J, Morichon L, Fortea J, Belbin O, Gabelle A, Blennow K, Zetterberg H, Lleo A, Lehmann S. Blood amyloid and tau biomarkers as predictors of cerebrospinal fluid profiles. J Neural Transm (Vienna). 2022 Feb;129(2):231-237. doi: 10.1007/s00702-022-02474-9. Epub 2022 Feb 15.
- Results publication: PubMed 34262030Lleo A, Zetterberg H, Pegueroles J, Karikari TK, Carmona-Iragui M, Ashton NJ, Montal V, Barroeta I, Lantero-Rodriguez J, Videla L, Altuna M, Benejam B, Fernandez S, Valldeneu S, Garzon D, Bejanin A, Iulita MF, Camacho V, Medrano-Martorell S, Belbin O, Clarimon J, Lehmann S, Alcolea D, Blesa R, Blennow K, Fortea J. Phosphorylated tau181 in plasma as a potential biomarker for Alzheimer's disease in adults with Down syndrome. Nat Commun. 2021 Jul 14;12(1):4304. doi: 10.1038/s41467-021-24319-x.
- Results publication: PubMed 34103344Alcolea D, Delaby C, Munoz L, Torres S, Estelles T, Zhu N, Barroeta I, Carmona-Iragui M, Illan-Gala I, Santos-Santos MA, Altuna M, Sala I, Sanchez-Saudinos MB, Videla L, Valldeneu S, Subirana A, Pegueroles J, Hirtz C, Vialaret J, Lehmann S, Karikari TK, Ashton NJ, Blennow K, Zetterberg H, Belbin O, Blesa R, Clarimon J, Fortea J, Lleo A. Use of plasma biomarkers for AT(N) classification of neurodegenerative dementias. J Neurol Neurosurg Psychiatry. 2021 Nov;92(11):1206-1214. doi: 10.1136/jnnp-2021-326603. Epub 2021 Jun 8.
- Derived from this study: PubMed 41980230Mondesert E, Cristol JP, Bargnoux AS, Duchiron M, Busto GU, Hirtz C, Barnier-Figue G, Perrein F, Turpinat C, Jurici S, Gabelle A, Bennys K, Lehmann S, Delaby C. Influence of Decreased Kidney Function on Plasma Biomarkers of Neurodegenerative Disorders in Routine Care: Confirmation of the Interest of Ratios. Neurology. 2026 May 12;106(9):e214931. doi: 10.1212/WNL.0000000000214931. Epub 2026 Apr 14.
- Clinical proteomicsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sylvain Lehmann, MD PhD principal investigator
University Hospital, Montpellier
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of amyloid and pTau blood biomarkers in people with Alzheimer Disease and Mild Cognitive Impairment, run by University Hospital, Montpellier at 3 sites in France.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of blood biomarkers for Alzheimer's disease (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05427448, which also lists 4 linked publications.
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 31 Dec 2025.