💬In plain words
What the trial is, and whether it could suit you
Apathy is a neurocognitive syndrome characterized by reduced goal-directed behaviors, contributing to decreased patient and caregiver quality of life. Apathy pathophysiology involves disruption of cortico-striato-thalamo-cortical loops, modulated by several neurotransmitter systems including dopamine and acetylcholine, thus complexifying pharmacological management. Post-stroke apathy (PSA) can provide a proper in vivo model to study the underlying neurochemical substrates of apathy as a syndrome. The present project aims to provide a better characterization of the cholinergic and dopaminergic functioning in apathy as a syndrome.
In order to precise the respective alterations of these two systems, investigators will use a positron emission tomography (PET) molecular imaging of dopaminergic (with \[18F\]-FDOPA, a marker of the decarboxylating enzyme of dopamine) and - for the first time i
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Patient of legal age and younger than 75 years
* Patient with a Rankin score less then or equal to 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)
Exclusion Criteria:
* 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, Hydroxyzine.
* Taking of any pharmacological treatment likely to affect 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)
* 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 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
HealthTeky