NCT06068361 Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach
| NCT ID | NCT06068361 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Lewy Bodies Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-09-11 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 130 participants in total. It began in 2024-09-11 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Dementia with Lewy body disease (DLB) is the second leading cause of degenerative cognitive disorder after Alzheimer's disease (AD). Its variable clinical expression makes diagnosis difficult. To date, there is no validated DLB diagnostic biomarker, despite several biomarkers in development (EEG, MRI, biology). Studies have shown that an improvement in diagnostic performance could be obtained by combining different modalities biomarkers using machine learning. The aim of this research is to identify the best combination of multimodal biomarkers for the diagnosis of DLB (EEG, MRI, biology, cognitive scores), using a machine learning approach applied to a clinical cohort.
Eligibility Criteria
Inclusion Criteria for DLB ant AD patients: * Neuropsychological assessment possible (good level in French language, absence of visual/auditory deficit limiting the cognitive assessment) * Dementia with Lewy bodies according to the revised criteria of Mc Keith 2017 or probable AD defined according to McKhann 2011 criteria including CSF biomarkers (an abnormal level of beta-amyloid 1-42 protein \[Ab42\] or a pathological Ab42/Ab40 ratio and an abnormal level of phosphorylated tau \[p-tau\]) Inclusion Criteria for control patients: * Neuropsychological assessment possible (good level in French language, absence of visual/auditory deficit limiting the cognitive assessment) * MMSE (Mini-mental State Examination) greater than or equal to 28, normal MemScreen test results, normal brain MRI and normal neurological examination Exclusion Criteria (for all) : * Contraindication to MRI * Other neurological or psychiatric or toxic/iatrogenic disorders that may account for the cognitive impairment or for EEG abnormalities * Any unstable medical pathology and/or that may account for the cognitive impairment
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06068361 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 85 Years, studying Lewy Bodies Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06068361 currently recruiting?
Yes, NCT06068361 is actively recruiting participants. Contact the research team at claire.paquet@aphp.fr for enrollment information.
Where is the NCT06068361 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06068361 clinical trial?
NCT06068361 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 130 participants.