Dementia With Lewy Bodies (DLB)QuIC-LewyNCT07166744
Contribution of Pathological Alpha-synuclein as a Diagnostic Biomarker for Dementia With Lewy Bodies
A study testing Biological : blood sampling, nasopharyngeal swab and Procedure : Lumbar puncture in people with Dementia With Lewy Bodies (DLB) and Alzheimer's Disease (AD), run by University Hospital, Strasbourg, France.
Trial summary
Alzheimer's disease and dementia with Lewy bodies (DLB) are the two main age-related neurodegenerative cognitive disorders. Differential diagnosis between these conditions is challenging, both at the prodromal and dementia stages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia With Lewy Bodies (DLB), Alzheimer's Disease (AD)
- What is being tested?
- Biological : blood sampling, nasopharyngeal swab and Procedure : Lumbar puncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jan 2032
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Patient, male or female, age equal or over 50 with signs suggestive of one of the following conditions: Lewy body disease (LBD) according to the criteria of McKeith et al. 2017 and 2020, + positive DAT-scan at inclusion applying, if necessary, usual biomarkers such as polysomnography and MIBG scintigraphy. Patients with non-significant (0 or 1 out of 3) Alzheimer's disease LCS biomarkers (P-Tau, Tau, and Abeta42/40) or Alzheimer's disease (AD) biomarkers (0 or 1 out of 3) will be considered as true MCL following lumbar puncture as part of the protocol.
- Alzheimer's disease (AD) according to the criteria of Dubois et al. 2014, or
- MCL + AD disease according to the criteria of McKeith et al. 2017 and 2020 + a positive DAT-scan at inclusion and Dubois et al. 2014, or
- Fronto-temporal diseases (FTD) in the broad sense: taupathy or tardopathy: fronto-temporal lobar dementia (FTLD) according to the criteria of Rascovsky et al., 2011, or cortico-basal degeneration (CBD) according to the criteria of Amstrong et al., 2013, or supranuclear palsy according to the criteria of Höglinger et al., 2017, or age-related predominantly limbic TDP-43 encephalopathy (LATE).
- Psychiatric disorders such as depression, bipolarity, schizophrenia according to DSM 5 criteria.
- Patient accompanied by a caregiver or a person likely to provide information about him/her (interview, telephone contact) in case the investigator deems the patient unable to provide this information alone.
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- Patient able to understand the aims and risks of the research and to give dated, signed informed consent (or consent given by the trusted support person/guardian, or in the presence of the curator if the patient is under guardianship or curatorship).
- Patient affiliated to a social health insurance protection.
- Patient presenting at syndromic level :
- either mild cognitive impairment (according to Petersen criteria) or mild, moderate or severe dementia (MMSE 30 to 5 included)
Who cannot join
- Patient with other neurological disease including, but not limited to, the following conditions: cerebral tumor, cerebrovascular accident with cognitive impairment, multisystem atrophy, etc, as judged by the investigator.
- Patient with a contraindication to lumbar puncture.
- Patient with a contraindication to cerebral MRI (patients included in Strasbourg only).
- Any reason making it impossible to follow up the patient during the study period (planned move, etc.).
- Patient under Legal safeguard ("sauvegarde de justice")- Impossibility of giving the patient informed information (patient in emergency or life-threatening situation).
- Patients under guardianship or curatorship may be included in the study; in fact, in severe to moderately severe patients (MMS<15), such a measure is often in place.
- -
About this study
Official title: Contribution of Pathological Alpha-Synuclein as a Diagnostic Biomarker for Dementia With Lewy Bodies
Alzheimer's disease and dementia with Lewy bodies (DLB) are the two main age-related neurodegenerative cognitive disorders. Differential diagnosis between these conditions is challenging, both at the prodromal and dementia stages. The lack of a precise diagnosis can be particularly harmful for patients with DLB, as up to 80% of them show severe adverse reactions to antipsychotic medications, including falls, confusion, and even death. The diagnosis of Alzheimer's disease has improved with cerebrospinal fluid (CSF) biomarkers such as Tau, phosphorylated Tau (P-Tau), and the Aβ42/Aβ40 ratio (Lehmann et al., 2018). However, differentiating Alzheimer's disease from DLB remains difficult: 1 to 3 Alzheimer's biomarkers are frequently positive in the CSF of patients with DLB: in 49% of cases at the prodromal stage and up to 72% at the dementia stage. Moreover, total α-synuclein measurement in CSF has not proven to be diagnostically reliable. The DAT-scan, sometimes used as a supportive tool, is an expensive technique and lacks sensitivity, with detection rates of only 78% in dementia-stage DLB and 54% in prodromal DLB.
Given these limitations, identifying specific biomarkers for DLB, particularly pathological α-synuclein, is a critical objective. α-synuclein is the main protein component of Lewy bodies, whose abnormal β-sheet conformation promotes aggregation and prion-like propagation. Conventional measurements of total α-synuclein in CSF have failed to achieve sufficient diagnostic specificity. In contrast, detecting aggregated or pathological forms of α-synuclein in CSF appears to be a promising approach for improving the diagnosis of synucleinopathies. New techniques based on α-synuclein aggregation amplification have shown encouraging results in retrospective studies including neuropathologically confirmed cases (Bargar et al., 2021; Rossi et al., 2020). However, prospective evaluation of these methods in real-world clinical settings is still lacking. We hypothesize that a specific assay targeting pathological α-synuclein in CSF could reliably distinguish patients with DLB from those with Alzheimer's disease.
- Being tested
- Biological : blood sampling, nasopharyngeal swab, Procedure : Lumbar puncture, Behavioral : clinical, functional, cognitive and psychiatric evaluations, MRI
- Medical subject headings
- Lewy Body Disease, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological : blood samplingOther
will be collected from the patient
nasopharyngeal swabOther
will be collected from the patient
Procedure : Lumbar punctureOther
will be collected from the patient
Behavioral : clinical, functional, cognitive and psychiatric evaluationsOther
will be collected from the patient
MRIOther
will be done on the patient
| Study group | Role | What they receive |
|---|---|---|
| Disease/dementia with lewy Bodies (DLB) | Experimental | Disease/Dementia with lewy bodies(DLB) according to the criteria of McKeith et al. 2017 and 2020, + positive DAT-scan at inclusion applying, if necessary, usual biomarkers such as polysomnography and MIBG scintigraphy. Patients with non-significant (0 or 1 out of 3) Alzheimer's disease LCS biomarkers (P-Tau, Tau, and Abeta42/40) will be considered as true MCL following lumbar puncture as part of the protocol.
* Biological : blood sampling, nasopharyngeal swab
* Procedure : Lumbar puncture
* Behavioral : clinical, functional, cognitive and psychiatric evaluations
* Other : MRI Receives: Other: Biological : blood sampling; Other: nasopharyngeal swab; Other: Procedure : Lumbar puncture; Other: Behavioral : clinical, functional, cognitive and psychiatric evaluations; Other: MRI |
| Alzheimer's disease arm | Active comparator | Alzheimer's disease (AD) according to the criteria of Dubois et al., 2014.
* Biological : blood sampling, nasopharyngeal swab
* Procedure : Lumbar puncture
* Behavioral : clinical, functional, cognitive and psychiatric evaluations Other : MRI Receives: Other: Biological : blood sampling; Other: nasopharyngeal swab; Other: Procedure : Lumbar puncture; Other: Behavioral : clinical, functional, cognitive and psychiatric evaluations; Other: MRI |
| Fronto-temporal diseases arm | Active comparator | Fronto-temporal disease (FTD) in the broad sense: taupathy or tardopathy: fronto-temporal lobar dementia (FTLD) according to the criteria of Rascovsky et al., 2011, or cortico-basal degeneration (CBD) according to the criteria of Amstrong et al., 2013, or supranuclear palsy according to the criteria of Höglinger et al., 2017, or Limbic-predominant age-related TDP-43 encephalopathy (LATE).
* Biological : blood sampling, nasopharyngeal swab
* Procedure : Lumbar puncture
* Behavioral : clinical, functional, cognitive and psychiatric evaluations Other : MRI Receives: Other: Biological : blood sampling; Other: nasopharyngeal swab; Other: Procedure : Lumbar puncture; Other: Behavioral : clinical, functional, cognitive and psychiatric evaluations; Other: MRI |
| Psychiatric disorders arm | Active comparator | Psychiatric disorders such as depression, bipolarity or schizophrenia, etc according to DSM 5 criteria.
* Biological : blood sampling, nasopharyngeal swab
* Procedure : Lumbar puncture
* Behavioral : clinical, functional, cognitive and psychiatric evaluations Other : MRI Receives: Other: Biological : blood sampling; Other: nasopharyngeal swab; Other: Procedure : Lumbar puncture; Other: Behavioral : clinical, functional, cognitive and psychiatric evaluations; Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the diagnostic value of pathological α-synuclein in cerebrospinal fluid (CSF) using lumbar puncture.
Pathological alpha-synuclein aggregation and amplification will be measured through its binding with fluorescent Thioflavin T. Fluorescence will be measured as a percentage using a spectrophotometer.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2032 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia With Lewy Bodies (DLB)Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166744
- Sponsor's protocol ID
- 9047
- Acronym
- QuIC-Lewy
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Pathological Alpha-Synuclein as a Diagnostic Biomarker for Dementia With Lewy Bodies
- ClinicalTrials.gov ID
- NCT07166744
- Acronym / sponsor ID
- QuIC-Lewy / 9047
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2032 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 10 Sep 2025 (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 and dementia with Lewy bodies (DLB) are the two main age-related neurodegenerative cognitive disorders. Differential diagnosis between these conditions is challenging, both at the prodromal and dementia stages. The lack of a precise diagnosis can be particularly harmful for patients with DLB, as up to 80% of them show severe adverse reactions to antipsychotic medications, including falls, confusion, and even death. The diagnosis of Alzheimer's disease has improved with cerebrospinal fluid (CSF) biomarkers such as Tau, phosphorylated Tau (P-Tau), and the Aβ42/Aβ40 ratio (Lehmann et al., 2018). However, differentiating Alzheimer's disease from DLB remains difficult: 1 to 3 Alzheimer's biomarkers are frequently positive in the CSF of patients with DLB: in 49% of cases at the prodromal stage and up to 72% at the dementia stage. Moreover, total α-synuclein measurement in CSF has not proven to be diagnostically reliable. The DAT-scan, sometimes used as a supportive tool, is an expensive technique and lacks sensitivity, with detection rates of only 78% in dementia-stage DLB and 54% in prodromal DLB.
Given these limitations, identifying specific biomarkers for DLB, particularly pathological α-synuclein, is a critical objective. α-synuclein is the main protein component of Lewy bodies, whose abnormal β-sheet conformation promotes aggregation and prion-like propagation. Conventional measurements of total α-synuclein in CSF have failed to achieve sufficient diagnostic specificity. In contrast, detecting aggregated or pathological forms of α-synuclein in CSF appears to be a promising approach for improving the diagnosis of synucleinopathies. New techniques based on α-synuclein aggregation amplification have shown encouraging results in retrospective studies including neuropathologically confirmed cases (Bargar et al., 2021; Rossi et al., 2020). However, prospective evaluation of these methods in real-world clinical settings is still lacking. We hypothesize that a specific assay targeting pathological α-synuclein in CSF could reliably distinguish patients with DLB from those with Alzheimer's disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Disease/dementia with lewy Bodies (DLB) | Experimental | Other: Biological : blood sampling, Other: nasopharyngeal swab, Other: Procedure : Lumbar puncture, Other: Behavioral : clinical, functional, cognitive and psychiatric evaluations, Other: MRIDisease/Dementia with lewy bodies(DLB) according to the criteria of McKeith et al. 2017 and 2020, + positive DAT-scan at inclusion applying, if necessary, usual biomarkers such as polysomnography and MIBG scintigraphy. Patients with non-significant (0 or 1 out of 3) Alzheimer's disease LCS biomarkers (P-Tau, Tau, and Abeta42/40) will be considered as true MCL following lumbar puncture as part of the protocol. * Biological : blood sampling, nasopharyngeal swab * Procedure : Lumbar puncture * Behavioral : clinical, functional, cognitive and psychiatric evaluations * Other : MRI |
| Alzheimer's disease arm | Active comparator | Other: Biological : blood sampling, Other: nasopharyngeal swab, Other: Procedure : Lumbar puncture, Other: Behavioral : clinical, functional, cognitive and psychiatric evaluations, Other: MRIAlzheimer's disease (AD) according to the criteria of Dubois et al., 2014. * Biological : blood sampling, nasopharyngeal swab * Procedure : Lumbar puncture * Behavioral : clinical, functional, cognitive and psychiatric evaluations Other : MRI |
| Fronto-temporal diseases arm | Active comparator | Other: Biological : blood sampling, Other: nasopharyngeal swab, Other: Procedure : Lumbar puncture, Other: Behavioral : clinical, functional, cognitive and psychiatric evaluations, Other: MRIFronto-temporal disease (FTD) in the broad sense: taupathy or tardopathy: fronto-temporal lobar dementia (FTLD) according to the criteria of Rascovsky et al., 2011, or cortico-basal degeneration (CBD) according to the criteria of Amstrong et al., 2013, or supranuclear palsy according to the criteria of Höglinger et al., 2017, or Limbic-predominant age-related TDP-43 encephalopathy (LATE). * Biological : blood sampling, nasopharyngeal swab * Procedure : Lumbar puncture * Behavioral : clinical, functional, cognitive and psychiatric evaluations Other : MRI |
| Psychiatric disorders arm | Active comparator | Other: Biological : blood sampling, Other: nasopharyngeal swab, Other: Procedure : Lumbar puncture, Other: Behavioral : clinical, functional, cognitive and psychiatric evaluations, Other: MRIPsychiatric disorders such as depression, bipolarity or schizophrenia, etc according to DSM 5 criteria. * Biological : blood sampling, nasopharyngeal swab * Procedure : Lumbar puncture * Behavioral : clinical, functional, cognitive and psychiatric evaluations Other : MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- - Patient, male or female, age equal or over 50 with signs suggestive of one of the following conditions: Lewy body disease (LBD) according to the criteria of McKeith et al. 2017 and 2020, + positive DAT-scan at inclusion applying, if necessary, usual biomarkers such as polysomnography and MIBG scintigraphy. Patients with non-significant (0 or 1 out of 3) Alzheimer's disease LCS biomarkers (P-Tau, Tau, and Abeta42/40) or Alzheimer's disease (AD) biomarkers (0 or 1 out of 3) will be considered as true MCL following lumbar puncture as part of the protocol.
- Alzheimer's disease (AD) according to the criteria of Dubois et al. 2014, or
- MCL + AD disease according to the criteria of McKeith et al. 2017 and 2020 + a positive DAT-scan at inclusion and Dubois et al. 2014, or
- Fronto-temporal diseases (FTD) in the broad sense: taupathy or tardopathy: fronto-temporal lobar dementia (FTLD) according to the criteria of Rascovsky et al., 2011, or cortico-basal degeneration (CBD) according to the criteria of Amstrong et al., 2013, or supranuclear palsy according to the criteria of Höglinger et al., 2017, or age-related predominantly limbic TDP-43 encephalopathy (LATE).
- Psychiatric disorders such as depression, bipolarity, schizophrenia according to DSM 5 criteria.
Key exclusion criteria (7 listed)
- Patient with other neurological disease including, but not limited to, the following conditions: cerebral tumor, cerebrovascular accident with cognitive impairment, multisystem atrophy, etc, as judged by the investigator.
- Patient with a contraindication to lumbar puncture.
- Patient with a contraindication to cerebral MRI (patients included in Strasbourg only).
- Any reason making it impossible to follow up the patient during the study period (planned move, etc.).
- Patient under Legal safeguard ("sauvegarde de justice")- Impossibility of giving the patient informed information (patient in emergency or life-threatening situation).
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 |
|---|---|---|
| Biological : blood samplingwill be collected from the patient | Other | Alzheimer's disease arm, Disease/dementia with lewy Bodies (DLB), Fronto-temporal diseases arm, Psychiatric disorders arm |
| nasopharyngeal swabwill be collected from the patient | Other | Alzheimer's disease arm, Disease/dementia with lewy Bodies (DLB), Fronto-temporal diseases arm, Psychiatric disorders arm |
| Procedure : Lumbar puncturewill be collected from the patient | Other | Alzheimer's disease arm, Disease/dementia with lewy Bodies (DLB), Fronto-temporal diseases arm, Psychiatric disorders arm |
| Behavioral : clinical, functional, cognitive and psychiatric evaluationswill be collected from the patient | Other | Alzheimer's disease arm, Disease/dementia with lewy Bodies (DLB), Fronto-temporal diseases arm, Psychiatric disorders arm |
| MRIwill be done on the patient | Other | Alzheimer's disease arm, Disease/dementia with lewy Bodies (DLB), Fronto-temporal diseases arm, Psychiatric disorders arm |
Primary outcome
Evaluation of the diagnostic value of pathological α-synuclein in cerebrospinal fluid (CSF) using lumbar puncture.
Time frame: Day 0
Pathological alpha-synuclein aggregation and amplification will be measured through its binding with fluorescent Thioflavin T. Fluorescence will be measured as a percentage using a spectrophotometer.
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 10 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Biological : blood sampling, nasopharyngeal swab and Procedure : Lumbar puncture in people with Dementia With Lewy Bodies (DLB) and Alzheimer's Disease (AD), run by University Hospital, Strasbourg, 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 10 inclusion and 7 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: opening soon, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Evaluation of the diagnostic value of pathological α-synuclein in cerebrospinal fluid (CSF) using lumbar puncture. (time frame: Day 0). 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 10 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.