2024-514530-21-00招募中4 期
Assessment of clozapine-related immunodeficiency effect in Parkinson's disease patients (CLOZIDPD)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- change in serum IgG levels before initiation of treatment with clozapine and then 6 months after initiation of treatment.
研究概览
简要总结
to evaluate the variation in the serum IgG level reflecting the humoral immune response 6 months after the initiation of treatment with Clozapine.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 18 years old with Parkinson's disease
- •Psychotic symptoms requiring initiation of treatment with Clozapine
排除标准
- •Patients with a contraindication to the use of Clozapine according to the summary of product characteristics (SPC)
- •Patient with another potential cause of immunosuppression
- •Patient with potentially major cognitive disorders defined by a MoCA score less than or equal to 23
结局指标
主要结局
change in serum IgG levels before initiation of treatment with clozapine and then 6 months after initiation of treatment.
change in serum IgG levels before initiation of treatment with clozapine and then 6 months after initiation of treatment.
次要结局
- The number of infections presented by the patient (oral collection during visits to M6 and M12)
- The variation in the patient's weight (weighed during visits D0, M6 and M12)
- The use of antibiotics by the patient (oral collection during visits to M6 and M12)
- Tolerance / adverse effects of treatment with Clozapine (collected during visits to M6 and M12)
- 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).
- - Variation in serum IgA level (on blood test taken on D0, M6 and M12)
- Variation in serum IgM level (on blood test taken on D0, M6 and M12)
- Variation in IgG levels with the IgG1, IgG2, IgG3 and IgG4 subclasses (on blood samples taken on D0, M6 and M12)
- Variation in CBC parameters (on blood test taken on D0, M6 and M12)
- Variation in CRP level (on blood test taken on D0, M6 and M12)
- Change in serum Clozapine level (on blood test taken at M6 and M12)
- Variation in T, B and NK lymphocyte subpopulations (on blood samples taken on D0, M6 and M12)
研究者
Dr Mickaël AUBIGNAT
Scientific
Centre Hospitalier Universitaire Amiens Picardie
研究点 (1)
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