2024-518721-15-00招募中3 期
In vivo involvement of the cholinergic and dopaminergic systems in the pathophysiology of apathy. ADACHOL.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- [18F]-FEOBV and [18F]-FDOPA binding intensities
研究概览
简要总结
To compare the integrity of cholinergic and dopaminergic pathways in apathetic (n = 15) and unapathetic (n = 15) patients, 3 to 7 months after stroke, matched in age and sex. It will be necessary to compare the binding intensity of cholinergic and dopaminergic tracers between the 2 groups of subjects.
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
- 是
入选标准
- •Patient of legal age and younger than 75 years
- •Patient with a Rankin score less than or equal to 2 and with or without apathy, demonstrated by AI scales, 3 to 7 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)
排除标准
- •Patients over 75 years old
- •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
- •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, Hydroxyzine
- •Taking of any pharmacological treatment likely to affect and dopaminergic systems at the time of PET-scan: glucagon, haloperidol, reserpin
- •White matter T2 hyperintense lesions (Fazekas score > 4)
- •NYHA Class III to IV Heart Failure Patient
- •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 visit
- •Patient with a chronic neurological disorder or severe psychiatric disorder
结局指标
主要结局
[18F]-FEOBV and [18F]-FDOPA binding intensities
[18F]-FEOBV and [18F]-FDOPA binding intensities
次要结局
- Clinical severity of apathy
- Functional connectivity parameters measured with MRI
- Diffusion tensor imaging parameters, such as the fractional anisotropy and mean diffusivity, measured with structural MRI
- Cerebral blood flow
研究者
Principal Investigator
Scientific
Centre Hospitalier Universitaire De Bordeaux
研究点 (1)
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