BridgeMD
In vivo involvement of the cholinergic and dopaminergic systems in the pathophysiology of apathy. ADACHOL.
EU CTIS ID: 2024-518721-15-00
What this study is testing
To compare the integrity of cholinergic and dopaminergic pathways in apathetic (n = 15) and unapathetic (n = 15) patients, 3 to 7 months after stroke, matched in age and sex. It will be necessary to compare the binding intensity of cholinergic and dopaminergic tracers between the 2 groups of subjects.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient of legal age and younger than 75 years
- 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)
- 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)
You likely can't join if
- Patients over 75 years old
- 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
See the full eligibility criteria
- Patient of legal age and younger than 75 years
- 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)
- 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)
- Patients over 75 years old
- 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
- 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 and dopaminergic systems at the time of PET-scan: glucagon, haloperidol, reserpin
- White matter T2 hyperintense lesions (Fazekas score > 4)
- 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 visit
- Patient with a chronic neurological disorder or severe psychiatric disorder
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.