Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach

ConditionsLewy Bodies Disease Alzheimer Disease Cognitive Impairment

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age55-85

SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

Treatment groups

130 Participants

are divided into 3 treatment groups

Sponsors and collaborators

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Association des Aidants et Malades à Corps de Lewy (A2MCL)

Collaborator

Source ClinicalTrials.gov