Exploration of GCase Activity to Identify a Subpopulation Eligible for a Therapeutic Trial in Dementia With Lewy Bodies
EGELY
Exploration of Glucocerebrosidase Activity to Identify a Subpopulation Eligible for a Therapeutic Trial in Dementia With Lewy Bodies
2 other identifiers
observational
236
1 country
1
Brief Summary
This research focuses on the activity of an enzymatic protein: glucocerebrosidase, in dementia with lewy bodies (DLB). Indeed, the mutation of the GBA gene responsible for a decrease in the activity of glucocerebrosidase is the most frequent known genetic risk factor in DLB. However, mutations of the GBA gene are known in another pathology, Gaucher disease, in which treatments have been developed. The objective of this research is to determine if glucocerebrosidase activity is decreased in DLB. This hypothesis could open up a therapeutic perspective, with treatments already used in Gaucher disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2022
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedStudy Start
First participant enrolled
February 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
November 20, 2025
November 1, 2025
3.3 years
January 27, 2022
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
GCase activity in patients and control by fluorometry
difference in measurement of glucocerebrosidase enzyme activity (by fluorometry method) between DLB patients and control subjects.
through study competion, an average of 1 year
Secondary Outcomes (5)
GBA gene and GCase activity
through study competion, an average of 1 year
MMSE score and GCase activity
through study competion, an average of 1 year
motor sub-score of UPDRS score and GCase activity
through study competion, an average of 1 year
GBA gene and macrophage abnormalities
through study competion, an average of 1 year
Treatment and macrophage biomarkers
through study competion, an average of 1 year
Study Arms (2)
DLB patients
Dementia with lewy bodies according to the revised criteria of Mc Keith 2017
Control
Absence of cognitive impairment and clinical element for a neurodegenerative disease
Interventions
Blood sample (20ml) for macrophage biomarkers
Eligibility Criteria
118 patients and 118 control subjects Patients and controls (often an accompanying person) will be selected during a routine visit for the patient's DLB
You may qualify if:
- Male or female aged ≥ 50 years old
- Presence of an accompanying person
- Dementia with lewy bodies according to the revised criteria of Mc Keith 2017
- Male or female aged ≥ 50 years old
- Absence of cognitive impairment and clinical element for a neurodegenerative disease
You may not qualify if:
- Other neurodegenerative disease
- Gaucher disease
- Neurodegenerative disease
- Cognitive impairment of all causes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre de neurologie Cognitive
Paris, France, 75010, France
Biospecimen
GBA gene
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2022
First Posted
March 31, 2022
Study Start
February 17, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
November 20, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share