In vivo involvement of the cholinergic and dopaminergic systems in the pathophysiology of apathy.

Phase 1

• Conditions: 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; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2018-003286-34-FR
• Lead Sponsor: CHU de Bordeaux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-10
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 30

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified