EUCTR2018-003286-34-FR进行中（未招募）1 期
In vivo involvement of the cholinergic and dopaminergic systems in the pathophysiology of apathy. - ADaChol
CHU de Bordeaux0 个研究点目标入组 30 人开始时间: 2018年9月10日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Patient of legal age and younger than 75 years
- •- Patient with a Rankin score ? 2 and with or without apathy, demonstrated by AI scales at 3 months after stroke (apathetic patient = AI scale score > 2)
- •- Affiliate or beneficiary of a social security scheme
- •- Subjects (female study subjects and female partners of male participants) using highly effective contraceptive methods (intra-uterine device, progestin or estrogen-progestin contraceptive, sterilization)
- •- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Patients over 75 years old
- •- Taking of any pharmacological treatment likely to affect cholinergic systems at the time of PET-scan : Amitriptyline, Atropine, Brompheniramine, Chlorphenamine, Chlorpromazine, Clomipramine, Clozapine, Dimenhydrinate, Diphenhydramine, Doxepine, Hyoscyamine, Imipramine, Meclozine, Nortriptyline, Oxybutynine, Promethazine, Scopolamine, Trimipramine
- •- Taking of any pharmacological treatment likely to affect and dopaminergic systems at the time of PET-scan: glucagon, haloperidol, reserpin
- •- Taking of any selective serotonine reuptake inhibitors treatment
- •- White matter T2 hyperintense lesions (Fazekas score > 3)
- •- Patients with allergy or conter-indication to entacapone
- •- Subjects with positive pregnancy test ((BHCG dosage and Urine dipstick), and/or currently breast-feeding
- •- Patients unable to come back to hospital for at least 2-follow-up visits
- •- Patient with a chronic neurological disorder or severe psychiatric disorder
- •- Patient with cognitive impairment (MoCA<24) and depression (CES-D score > 17 for men and >23 for women)
- •- Patient presenting a counter-indication for MRI
- •- Patient presenting a counter-indication for TEP with [18F]-FEOBV or [18F]-FDOPA (known allergy)
- •- Patient who underwent a PET examination in the previous month
- •- Patient with state of health not allowing a displacement in the department of imaging of the CHU: bedridden state, state of health very deteriorated
- •- Patient deprived of liberty by judicial or administrative decision
- •- Patient under legal protection or unable to express its own consent
- •- Subject within exclusion period from another clinical trial
研究者
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