NCT07166744 · NOT YET RECRUITING
Contribution of Pathological Alpha-synuclein as a Diagnostic Biomarker for Dementia With Lewy Bodies
This study is testing whether a specific lab measurement of abnormal alpha-synuclein protein, drawn from spinal fluid, a nasal swab, and blood, can reliably tell apart dementia with Lewy bodies from Alzheimer's disease. Right now, those two conditions are often confused, which is dangerous because common medications can severely harm Lewy body patients. This is a Phase NA diagnostic accuracy study, meaning it is evaluating a test, not a treatment.
Eligibility criteria
Inclusion Criteria:
* - 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 Criteria:
* 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.
-The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-09-10