EUCTR2018-003286-34-FR
Active, not recruiting
Phase 1
In vivo involvement of the cholinergic and dopaminergic systems in the pathophysiology of apathy. - ADaChol
CHU de Bordeaux0 sites30 target enrollmentSeptember 10, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CHU de Bordeaux
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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)
Outcomes
Primary Outcomes
Not specified
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