Clinical trial Recruiting at 1 site Observational Ages 55 to 85

Evaluating diagnostic methods for Dementia with Lewy Bodies

Official title: Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach: EEG, Cognitive, Biological and MRI Biomarkers

Run by Assistance Publique - Hôpitaux de Paris · NCT06068361 · Data updated 2026-11-12

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.

More Cognitive Impairment trials

Quick facts

Study typeObservational
Ages55 Years to 85 Years
SexAll
Enrollment130 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Locations1 site (Paris, France)
StatusRecruiting
StartedSeptember 11, 2024
Main results expectedSeptember 2027
Study endsSeptember 2027
Registry record updatedMarch 27, 2025
Trial IDNCT06068361 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals diagnosed with probable DLB or Alzheimer's disease, as well as control subjects with subjective cognitive impairment.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Centre de neurologie Cognitive
    Paris, France, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.