2023-504181-38-00招募中3 期
Assessment of microglial activation in patients with schizophrenia stratified for C4 complement by PET using [18F]DPA-714
Institut National De La Sante Et De La Recherche Medicale2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年5月26日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- The main evaluation criterion is the level of microglial activation measured in PET with [ 18F]-DPA714 in the brain, which will be compared between groups according to the genotype of C4 weighted by the ancestral haplotype that carries it
研究概览
简要总结
To assess the correlation between cortical neuro-inflammation quantified by Positrons Emission Tomography (PET) using [18F]DPA-714, and genetic determinants of C4 expression in patients with schizophrenia and healthy volunteers.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Male or Female, aged from 18 to 55, patients with schizophrenia diagnostic according to DSM-5 and presenting HLA 8.1 AH haplotype (8.1 AH+) or presenting no HLA 8.1 AH haplotype ( (8.1 AH-)
- •Male or Female healthy controls aged from 18 to 55 matched regarding age, sex, HLA/C4 according to patients (8.1 AH+ or 8.1 AH-).
- •Having Efficient Contraception for women of reproductive age ( contraception will be considered effective from the moment the patient declares the use of an oral contraceptive, the presence of an IUD other than copper ones, a diaphragm or a contraceptive implant, or the completion of a tubal ligation or sterilization by Essure process)
- •Be able to understand research objectives and procedures
- •Be affiliated with or be a beneficiary of a social security scheme
- •Genetic criterion: TSPO genotype allowing tracer fixation (90% of subjects)
- •Have signed a free and informed consent
排除标准
- •Progressive chronic inflammatory disease (rheumatic, digestive, autoimmune)
- •Adult subject to legal protection (guardianship of a tutor, or safeguard of justice)
- •For healthy volunteers only : Pathology or history of Axis 1 psychiatric pathology investigated by the validated French version of the MINI (Mini International Neuropsychiatric Interview) questionnaire
- •Known hypersensitivity to radiopharmaceutical ([18F]DPA-714 or one of the excipients)
- •History of severe renal or liver failure
- •Contraindication to MRI : pacemaker or neurosensory pacemaker or implantable defibrillator; clip on an aneurysm or clip on a vascular malformation of the brain; ferromagnetic intraocular or cerebral foreign body; prosthesis or ferro-metallic objects or fragments mobilizable magnetic; cochlear implants; peripheral stimulator; ventriculoperitoneal neurosurgical bypass valves; permanent eye or lip makeup. Automatic injection device type insulin pump, blood glucose sensor
- •Claustrophobia
- •Current pregnancy, breastfeeding
- •Person refusing to be informed of a significant health finding discovered in the research
- •Participation in research or management of a pathology with ionizing radiation exposure as part of a nuclear medicine examination (PET, SPECT, NM) in the year prior to or during the exclusion period of another research
- •Person deprived of liberty by administrative or judicial decision
结局指标
主要结局
The main evaluation criterion is the level of microglial activation measured in PET with [ 18F]-DPA714 in the brain, which will be compared between groups according to the genotype of C4 weighted by the ancestral haplotype that carries it
The main evaluation criterion is the level of microglial activation measured in PET with [ 18F]-DPA714 in the brain, which will be compared between groups according to the genotype of C4 weighted by the ancestral haplotype that carries it
次要结局
- - Regional cortical thicknesses as determined on anatomical MRI
- Parameters of subcortical brain connectivity (variables derived from diffusion MRI such as fractional anisotropy and resting functional MRI such as functional connectivity) which will be compared between groups according to the C4 genotype.
- Lipid abnormalities (cholesterol, serum triglycerides), blood glucose, peripheral markers of inflammation (CRP, cytokines) and clinical parameters (abdominal tension, abdominal girth) will also be correlated to the level of microglial activation measured in PET
研究者
Corentin LE-MARGUERESSE
Scientific
Institut National De La Sante Et De La Recherche Medicale
研究点 (2)
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