Alzheimer Blood BiomarkersPLASM-ALZNCT06304129
Diagnostic Performance of Plasma Biomarkers of Alzheimer's Disease Compared With CSF Markers
A study testing Blood ponction in people with Alzheimer Blood Biomarkers, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
.The goal of this interventional study is to estimate the diagnostic performance of plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL), enabling discrimination between patients with and without a pathophysiological AD process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Blood Biomarkers
- What is being tested?
- Blood ponction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteFrance
- Study dates
- 2 Apr 2024to 2 Sep 2026
- 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
- Man or woman aged 18 or over
- Person affiliated to a social security scheme or beneficiary of such a scheme
- Person who has received full information on the organization of the research and has signed an informed consent form
- Person whose care requires a lumbar puncture to measure markers of Alzheimer's disease
Who cannot join
- Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
- An adult unable to give consent
- Persons deprived of their liberty by judicial or administrative decision
- Persons under psychiatric care under articles L. 3212-1 and L. 3213-1.
- Pregnant, parturient or breast-feeding women
- Persons staying in a health or social establishment for purposes other than research.
Trial locations and contacts
1 site in 1 country.
Thérèse Jonveaux, PhD, MD contact
About this study
Official title: Threshold Values and Diagnostic Performance of Plasma Biomarkers of Alzheimer's Disease Compared With CSF Markers
.The goal of this interventional study is to estimate the diagnostic performance of plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL), enabling discrimination between patients with and without a pathophysiological AD process. The main questions it aims to answer are:
- to define a threshold value for each of the plasma,
- to describe the correlations between the plasma biomarkers of interest and the other biological analyses performed as part of care, in particular triglyceridemia, cholesterolemia, glycemia and proteinemia,
- to describe biomarker results in relation to comorbidities, in particular dyslipidemia and diabetes
- to describe the final diagnosis and results obtained for plasma biomarkers, for patients with intermediate results according to the A/T/N classification (A-/T+ or A+/T-) Participants will be selected among patients undergoing lumbar puncture for the differential diagnosis of AD at Nancy University Hospital.
- Conditions
- Alzheimer Blood Biomarkers
- Being tested
- Blood ponction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood ponctionDiagnostic test
Blood ponction
| Study group | Role | What they receive |
|---|---|---|
| Blood ponction | Experimental | All patients are in the experimental group Receives: Diagnostic Test: Blood ponction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aβ40 and Aβ42, P-Tau, Tau and NFL
Peptides Aβ40 and Aβ42, P-Tau and NFL, assayed in plasma. Peptides Aβ40 and Aβ42, Tau and P-Tau assayed in CSF
Measured: 2 years
Secondary outcomes (3)
Sensitivity/specificity
sensitivity, specificity, positive predictive value and negative predictive value of the plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL) according to the defined threshold value, with reference to the A/T/N classification
Measured: 2 years
Co-mobidity
results of assays for plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL) in subgroups of patients with co-morbidities (notably dyslipidemia, diabetes)
Measured: 2 years
Final diagnosis
final diagnosis selected according to criteria used in clinical practice (based on a multidisciplinary approach including analysis of biological results) and measurement of plasma biomarkers (Aβ40 and Aβ42, P-Tau and NFL) in the subgroup of patients with intermediate results according to the A/T/N classification (A-/T+ or A+/T-)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start2 Apr 2024 (estimated)
- Primary completion2 Jan 2026 (estimated)
- Study completion2 Sep 2026 (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.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Thérèse Jonveaux, Laure Joly, Lucie Hopes, Maia Simon, Franck Schreiner
- Responsible party
- Principal investigator, Catherine MALAPLATE, Central Hospital, Nancy, France
- Investigators
- Catherine Malaplate, PhD, PharmD, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304129
- Sponsor's protocol ID
- 2023-A00709-36
- Acronym
- PLASM-ALZ
- Status last verified
- Sep 2023
- First submitted
- 5 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Threshold Values and Diagnostic Performance of Plasma Biomarkers of Alzheimer's Disease Compared With CSF Markers
- ClinicalTrials.gov ID
- NCT06304129
- Acronym / sponsor ID
- PLASM-ALZ / 2023-A00709-36
- Conditions
- Alzheimer Blood Biomarkers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Thérèse Jonveaux, Laure Joly, Lucie Hopes, Maia Simon, Franck Schreiner
- Study start
- 2 Apr 2024 (estimated)
- Primary completion
- 2 Jan 2026 (estimated)
- Study completion
- 2 Sep 2026 (estimated)
- First posted
- 12 Mar 2024 (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.
.The goal of this interventional study is to estimate the diagnostic performance of plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL), enabling discrimination between patients with and without a pathophysiological AD process. The main questions it aims to answer are:
- to define a threshold value for each of the plasma,
- to describe the correlations between the plasma biomarkers of interest and the other biological analyses performed as part of care, in particular triglyceridemia, cholesterolemia, glycemia and proteinemia,
- to describe biomarker results in relation to comorbidities, in particular dyslipidemia and diabetes
- to describe the final diagnosis and results obtained for plasma biomarkers, for patients with intermediate results according to the A/T/N classification (A-/T+ or A+/T-) Participants will be selected among patients undergoing lumbar puncture for the differential diagnosis of AD at Nancy University Hospital.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood ponction | Experimental | Diagnostic Test: Blood ponctionAll patients are in the experimental group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Man or woman aged 18 or over
- Person affiliated to a social security scheme or beneficiary of such a scheme
- Person who has received full information on the organization of the research and has signed an informed consent form
- Person whose care requires a lumbar puncture to measure markers of Alzheimer's disease
Key exclusion criteria (6 listed)
- Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
- An adult unable to give consent
- Persons deprived of their liberty by judicial or administrative decision
- Persons under psychiatric care under articles L. 3212-1 and L. 3213-1.
- Pregnant, parturient or breast-feeding 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 |
|---|---|---|
| Blood ponctionBlood ponction | Diagnostic test | Blood ponction |
Primary outcome
Aβ40 and Aβ42, P-Tau, Tau and NFL
Time frame: 2 years
Peptides Aβ40 and Aβ42, P-Tau and NFL, assayed in plasma. Peptides Aβ40 and Aβ42, Tau and P-Tau assayed in CSF
3 secondary outcomes
Sensitivity/specificity
Time frame: 2 years
Co-mobidity
Time frame: 2 years
Final diagnosis
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
Thérèse Jonveaux, PhD, MD contact
Catherine Malaplate, PhD, PharmD principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood ponction in people with Alzheimer Blood Biomarkers, run by Central Hospital, Nancy, France at 1 site 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact catherine Malaplate, PhD,PharmD (+33383855511, c.malaplate@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aβ40 and Aβ42, P-Tau, Tau and NFL (time frame: 2 years). 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 12 Mar 2024.