FLUOROETHOXYBENZOVESAMICOL F-18 for Apathy | Stroke

Inclusion criteria

• {"criterion_text":"- Patient of legal age and younger than 75 years\n- 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)\n- Affiliate or beneficiary of a social security scheme\n- Subjects (female study subjects and female partners of male participants) using highly effective contraceptive methods (intra-uterine device, progestin or estrogen-progestin contraceptive, sterilization)\n- 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

• {"criterion_text":"- Patients over 75 years old\n- 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\n- Taking of any pharmacological treatment likely to affect and dopaminergic systems at the time of PET-scan: glucagon, haloperidol, reserpin\n- White matter T2 hyperintense lesions (Fazekas score > 4)\n- NYHA Class III to IV Heart Failure Patient\n- Patients with allergy or conter-indication to entacapone\n- Subjects with positive pregnancy test ((BHCG dosage and Urine dipstick), and/or currently breast-feeding\n- Patients unable to come back to hospital for at least 2-follow-up visit\n- Patient with a chronic neurological disorder or severe psychiatric disorder\n- Patient presenting a counter-indication for MRI\n- Patient presenting a counter-indication for TEP with [18F]-FEOBV or [18F]-FDOPA (known allergy)\n- Patient who underwent a PET examination in the previous month\n- Patient with state of health not allowing a displacement in the department of imaging of the CHU: bedridden state, state of health very deteriorated\n- Patient deprived of liberty by judicial or administrative decision\n- Patient under legal protection or unable to express its own consent\n- Subject within exclusion period from another clinical trial"}

Primary endpoints

• {"endpoint_text":"- [18F]-FEOBV and [18F]-FDOPA binding intensities","definition_or_measurement_approach":"Values of cerebral binding parameters for the cholinergic ([18F]-FEOBV) and dopaminergic ([18F]-FDOPA) tracers assessed by PET imaging; comparison of tracer binding intensity between apathetic and non-apathetic post-stroke groups."}

Secondary endpoints

• {"endpoint_text":"- Clinical severity of apathy\n- Functional connectivity parameters measured with MRI\n- Diffusion tensor imaging parameters, such as the fractional anisotropy and mean diffusivity, measured with structural MRI\n- Cerebral blood flow","definition_or_measurement_approach":"Clinical severity of apathy: apathy scale (AI) score; Functional connectivity: maps of correlation coefficients between brain regions measured with resting-state fMRI; DTI parameters: fractional anisotropy and mean diffusivity measured on structural MRI diffusion sequences; Cerebral blood flow: perfusion maps (e.g. arterial spin labeling) measuring cerebral perfusion."}

France

Earliest CTIS Part Ii Submission Date

08-11-2024

Latest Decision Or Authorization Date

14-11-2024

Processing Time Days

6

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Bordeaux

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"LabEx BRAIN","duties_or_roles":"Monetary support","organisation_type":""}