CLOZAPINE for Parkinson's disease

Inclusion criteria

• {"criterion_text":"- Patient ≥ 18 years old with Parkinson's disease"}
• {"criterion_text":"- Psychotic symptoms requiring initiation of treatment with Clozapine"}

Exclusion criteria

• {"criterion_text":"- Patients with a contraindication to the use of Clozapine according to the summary of product characteristics (SPC)"}
• {"criterion_text":"- Patient with another potential cause of immunosuppression"}
• {"criterion_text":"- Patient with potentially major cognitive disorders defined by a MoCA score less than or equal to 23"}

Primary endpoints

• {"endpoint_text":"- change in serum IgG levels before initiation of treatment with clozapine and then 6 months after initiation of treatment.","definition_or_measurement_approach":"Serum IgG level measured at baseline (before initiation of clozapine) and at 6 months after initiation to evaluate variation reflecting humoral immune response."}

Secondary endpoints

• {"endpoint_text":"- The variation in the patient's weight (weighed during visits D0, M6 and M12)","definition_or_measurement_approach":"Weight measured at visits D0, M6 and M12."}
• {"endpoint_text":"- The number of infections presented by the patient (oral collection during visits to M6 and M12)","definition_or_measurement_approach":"Oral collection of infection history during visits up to M6 and M12."}
• {"endpoint_text":"- The use of antibiotics by the patient (oral collection during visits to M6 and M12)","definition_or_measurement_approach":"Oral collection of antibiotic use during visits up to M6 and M12."}
• {"endpoint_text":"- Tolerance / adverse effects of treatment with Clozapine (collected during visits to M6 and M12)","definition_or_measurement_approach":"Collection of tolerance/adverse effects at M6 and M12 visits."}
• {"endpoint_text":"- Variation in motor status, quality of life, depressive syndrome, apathy, global cognitive efficiency and psychotic elements assessed on the clinical scales MDS-UPDRS, PDQ39, Goldberg, Starkstein, MoCA and the neuropsychological inventory (NPI) (carried out during visits D0, M6 and M12).","definition_or_measurement_approach":"Clinical scales (MDS-UPDRS, PDQ39, Goldberg, Starkstein, MoCA, NPI) administered at D0, M6 and M12 to assess changes."}
• {"endpoint_text":"- - Variation in serum IgA level (on blood test taken on D0, M6 and M12)","definition_or_measurement_approach":"Serum IgA measured on blood samples at D0, M6 and M12."}
• {"endpoint_text":"- Variation in serum IgM level (on blood test taken on D0, M6 and M12)","definition_or_measurement_approach":"Serum IgM measured on blood samples at D0, M6 and M12."}
• {"endpoint_text":"- Variation in IgG levels with the IgG1, IgG2, IgG3 and IgG4 subclasses (on blood samples taken on D0, M6 and M12)","definition_or_measurement_approach":"IgG subclasses (IgG1-4) measured on blood samples at D0, M6 and M12."}
• {"endpoint_text":"- Variation in CBC parameters (on blood test taken on D0, M6 and M12)","definition_or_measurement_approach":"Complete blood count parameters assessed on blood tests at D0, M6 and M12."}
• {"endpoint_text":"- Variation in CRP level (on blood test taken on D0, M6 and M12)","definition_or_measurement_approach":"C-reactive protein measured on blood tests at D0, M6 and M12."}
• {"endpoint_text":"- Change in serum Clozapine level (on blood test taken at M6 and M12)","definition_or_measurement_approach":"Serum clozapine concentration measured at M6 and M12."}
• {"endpoint_text":"- Variation in T, B and NK lymphocyte subpopulations (on blood samples taken on D0, M6 and M12)","definition_or_measurement_approach":"T, B and NK lymphocyte subpopulations assessed on blood samples at D0, M6 and M12."}

France

Earliest CTIS Part Ii Submission Date

22-07-2024

Latest Decision Or Authorization Date

23-08-2024

Processing Time Days

32

Number Of Sites

1

Number Of Participants

24

Primary sponsor

Full Name

Centre Hospitalier Universitaire Amiens Picardie

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France