Combining tests to better diagnose dementia with Lewy bodies
Studies brain waves, memory tests, blood markers and brain scans in people with memory problems.
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Paris, FranceSee the site
- Trial code
- Registry title
- Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach
- Status
- Recruiting
- People taking part
- 130 people, planned
- Started
- 11 Sept 2024
- Expected to end
- Sept 2027
- Type of study
- Observational, 3 groups
- Treatments tested
- EEG
- Record updated
- 27 March 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 55 to 85 with dementia with Lewy bodies or Alzheimer's disease, and for people with normal memory and thinking as controls.
- Age
- 55 to 85 years
- Sex
- All sexes can join.
- Disease stage
- Dementia with Lewy bodies by the McKeith 2017 criteria, or probable Alzheimer's disease by the McKhann 2011 criteria with abnormal spinal fluid markers. Controls need an MMSE score of 28 or more, a normal MemScreen test, a normal brain MRI and a normal neurological exam.
- Biomarker or test result
- For Alzheimer's disease: abnormal beta-amyloid 1-42 (Ab42) or an abnormal Ab42/Ab40 ratio, and abnormal phosphorylated tau (p-tau) in the spinal fluid.
Main reasons for not taking part
- Cannot have an MRI scan
- Other nerve, mental or toxic/medicine-related problems that could explain the memory problems or EEG changes
- Unstable medical illness that could explain the memory problems
- Cannot do the memory and thinking tests (poor French, or vision or hearing problems)
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Contraindication to MRI
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 85 years old?
Where in France
- Centre de neurologie CognitiveParis, FranceContact: Claire PAQUET, MDPhDTaking people
About the trial
What the trial wants to find out
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).
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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.
The 3 groups in the trial
- DLB patients
Dementia with Lewy bodies according to the revised criteria of Mc Keith 2017
Treatment: EEG
- AD patients
Alzheimer's disease according to McKhann et al., 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 \[p-tau\])
Treatment: EEG
- Control
Subjective cognitive complaint, with a normal brain MRI and neurological examination, without any elements in favor of a neurodegenerative disease
Treatment: EEG
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach: EEG, Cognitive, Biological and MRI Biomarkers
- Plain-language title
- Combining tests to better diagnose dementia with Lewy bodiesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06068361, who can take part
- Record updated
- 27 March 2025