Apathy MedDRA version: 20.0 Level: PT Classification code 10002942 Term: Apathy System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0 Level: LLT Classification code 10042244 Term: Stroke System Organ Class: 100000004852
Conditions
Interventions
Product Name: [18F]-fluoroéthoxybenzovésamicol
Product Code: [18F]-FEOBV
Pharmaceutical Form: Solution for injection
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
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 - 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): [18F]-FEOBV nondisplaceable binding potential (BPND) and [18F]-FDOPA binding ratio; Timepoint(s) of evaluation of this end point: Visit 1 Visit 2 ;Main Objective: To compare the integrity of cholinergic and dopaminergic pathways in apathetic (n = 15) and unapathetic (n = 15) patients 3 months after stroke, matched in age and sex. It will be necessary to compare the binding intensity of cholinergic and dopaminergic tracers (estimated in PET by the measurement of either the nondisplaceable Binding Potential, BPND, or a binding ratio) between the 2 groups of subjects.; Secondary Objective: 1. To assess whether modifications of cholinergic and dopaminergic activities can be linked with the clinical expression of apathy. 2. To assess whether cholinergic and dopaminergic dysfunctions can be linked with alterations in the functional organization of the resting brain. 3. To assess whether modifications of cholinergic and dopaminergic activities can be linked with specific local changes in white matter microstructure. 4. To investigate whether the binding intensity of cholinergic and dopaminergic tracers is dependent on cerebral blood flow disorders, as shown on the cerebral blood flow maps provided by arterial spin labeling sequences. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Binding intensity of cholinergic and dopaminergic tracers - 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 ; Timepoint(s) of evaluation of this end point: Inclusion Visit 1 Visit 2 | — |
Countries
France
Contacts
Public ContactResponsable Etudes Cliniques
CHU de Bordeaux
Outcome results
None listed