Alzheimer Disease Clinical Trial
— EEG-EDELYOfficial title:
Diagnostic Evaluation of Dementia With Lewy Bodies Using a Multimodal Approach: EEG, Cognitive, Biological and MRI Biomarkers
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.
Status | Not yet recruiting |
Enrollment | 130 |
Est. completion date | July 2027 |
Est. primary completion date | July 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre de neurologie Cognitive | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Association des Aidants et Malades à Corps de Lewy (A2MCL) |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic performance of a composite multimodal score | Diagnostic performance (sensitivity, specificity, accuracy) of a composite multimodal score combining quantitative EEG metrics, plasma biomarkers, MRI volumetric markers and cognitive scores, to differentiate groups of patients (AD, DLB) and control subjects. | 24 month | |
Secondary | Comparison between groups of patients and controls of a composite EEG score combining several quantitative EEG parameters. | 24 month | ||
Secondary | Correlation between EEG parameters, biological biomarkers, MRI volumetric markers and cognitive scores assessed in the three groups (DLB, AD, controls) | 24 month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04079803 -
PTI-125 for Mild-to-moderate Alzheimer's Disease Patients
|
Phase 2 | |
Completed |
NCT04044495 -
Sleep, Rhythms and Risk of Alzheimer's Disease
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Recruiting |
NCT04520698 -
Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease
|
N/A | |
Active, not recruiting |
NCT04606420 -
Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease
|
N/A | |
Recruiting |
NCT05820919 -
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
|
N/A | |
Terminated |
NCT03672474 -
REGEnLIFE RGn530 - Feasibility Pilot
|
N/A | |
Completed |
NCT03430648 -
Is Tau Protein Linked to Mobility Function?
|
||
Recruiting |
NCT04949750 -
Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease
|
N/A | |
Recruiting |
NCT04522739 -
Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease
|
Phase 4 | |
Recruiting |
NCT05557409 -
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
|
Phase 3 | |
Recruiting |
NCT05288842 -
Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
|
||
Completed |
NCT06194552 -
A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07
|
Phase 1 | |
Completed |
NCT03239561 -
Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants
|
Early Phase 1 | |
Completed |
NCT03184467 -
Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
Terminated |
NCT03487380 -
Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Recruiting |
NCT05328115 -
A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease
|
Phase 1 | |
Completed |
NCT05562583 -
SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support
|
N/A |