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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05304195
Other study ID # APHP201175
Secondary ID 2021-A02345-36
Status Recruiting
Phase
First received
Last updated
Start date February 17, 2023
Est. completion date June 2025

Study information

Verified date February 2023
Source Assistance Publique - Hôpitaux de Paris
Contact Claire HOURREGUE, MD
Phone 0140054313
Email claire.hourregue@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Population: 118 patients and 118 control subjects Act of research: blood test Objectifs : - Comparison of glucocerebrosidase activity between patients and controls - Search for variants or mutations of the GBA gene and correlation with glucocerebrosidase activity - Correlation between clinical characteristics (UPDRS motor scale, MMSE cognitive scale) and GCase activity in patients


Recruitment information / eligibility

Status Recruiting
Enrollment 236
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria for patients : - 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 Inclusion Criteria for controls: - Male or female aged = 50 years old - Absence of cognitive impairment and clinical element for a neurodegenerative disease Exclusion Criteria for patients: - Other neurodegenerative disease - Gaucher disease Exclusion Criteria for controls: - Neurodegenerative disease - Cognitive impairment of all causes

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Glucocerebrosidase
Blood sample (10ml) for GCase activity
Genetic:
GBA gene
Blood sample (10ml) for variants or mutations of the GBA gene

Locations

Country Name City State
France Centre de neurologie Cognitive Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 GBA gene and GCase activity correlation between the presence of GBA gene mutation and the measurement of glucocerebrosidase enzymatic activity through study competion, an average of 1 year
Secondary MMSE score and GCase activity correlation between the measurement of glucocerebrosidase enzymatic activity and MMSE score (Mini-Mental State Examination from 0-severe to 30-normal) of DLB patients through study competion, an average of 1 year
Secondary motor sub-score of UPDRS score and GCase activity correlation between the measurement of glucocerebrosidase enzymatic activity and motor sub-score of UPDRS score (motor sub-score of Unified Parkinson Disease Rating Scale from) of DLB patients The score is between 0 and 55. The score increases proportionally to the severity of the extrapyramidal syndrome. through study competion, an average of 1 year
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