Evaluating diagnostic methods for Dementia with Lewy Bodies
Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach: EEG, Cognitive, Biological and MRI Biomarkers
This study is testing a new way to diagnose Dementia with Lewy Bodies by using different brain scans and blood tests to see if they can improve accuracy for patients with this condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 55 Years to 85 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, France) |
| Trial ID | NCT06068361 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the diagnosis of Dementia with Lewy Bodies (DLB) by utilizing a multimodal approach that combines EEG, MRI, and plasma biomarkers. Over a period of 24 months, the study will include 50 probable DLB patients, 50 Alzheimer's disease patients, and 30 control subjects. The research will employ machine learning techniques to analyze the data collected from various diagnostic modalities, with the goal of identifying the most effective combination for accurate diagnosis. The study is conducted at the Cognitive Neurology Center in Paris.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with probable DLB or Alzheimer's disease, as well as control subjects with subjective cognitive impairment.
Not a fit: Patients with contraindications to MRI or those with other neurological or psychiatric disorders that could affect cognitive assessment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely diagnoses of Dementia with Lewy Bodies, improving patient management and treatment outcomes.
How similar studies have performed: Other studies have shown promise in using multimodal approaches and machine learning for improving diagnostic accuracy in neurodegenerative diseases, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris, France
- Centre de neurologie Cognitive — Paris, France, France (Recruiting)
Study contacts
- Study coordinator: Claire PAQUET, MDPhD
- Email: claire.paquet@aphp.fr
- Phone: 0140054313
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.