Status:
RECRUITING
Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Association des Aidants et Malades à Corps de Lewy (A2MCL)
Conditions:
Lewy Bodies Disease
Alzheimer Disease
Eligibility:
All Genders
55-85 years
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...
Detailed Description
Study population: Observational prospective cohort study including over 24 months at the GHU AP-HP. Nord Lariboisière, Cognitive Neurology Center : 50 probable DLB patients, 50 AD patients, and 30 con...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 11 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06068361
Start Date
September 11 2024
End Date
September 1 2027
Last Update
March 27 2025
Active Locations (1)
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1
Centre de neurologie Cognitive
Paris, France, France, 75010