Status:
NOT_YET_RECRUITING
Contribution of Pathological Alpha-synuclein as a Diagnostic Biomarker for Dementia With Lewy Bodies
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Dementia With Lewy Bodies (DLB)
Alzheimer's Disease (AD)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- \- 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.
- 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)
Exclusion
- 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.
- \-
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2032
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT07166744
Start Date
January 1 2026
End Date
January 1 2032
Last Update
September 10 2025
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