NCT06068361Recruiting
Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach
Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach: EEG, Cognitive, Biological and MRI Biomarkers
Source: ClinicalTrials.gov · Last updated 27 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 130 (estimated)
- First submitted
- 29 Sept 2023
- Start date
- 11 Sept 2024
- Primary completion date
- Sept 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Lewy body dementia, Alzheimer disease
- NCT number
- NCT06068361
What you commit to
- Study type: Observational
- Planned participants: 130
- From 11 Sept 2024 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Contraindication to MRI
Who the study is looking for
- 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 \[p-tau\])
- 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
Age in the registry: 55 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre de neurologie Cognitive Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.