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New treatment option for Apathy
Official title In Vivo Involvement of the Cholinergic and Dopaminergic Systems in the Pathophysiology of Apathy.
ClinicalTrials.gov ID: NCT03998852
What this study is testing
What is Positron Emission Tomography (PET) with [18F]-FDOPA?
Positron Emission Tomography (PET) with [18F]-FDOPA is an investigational medicine, being studied as a potential treatment for apathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Apathy is a neurocognitive syndrome characterized by reduced goal-directed behaviors, contributing to decreased patient and caregiver quality of life. Apathy pathophysiology involves disruption of cortico-striato-thalamo-cortical loops, modulated by several neurotransmitter systems including dopamine and acetylcholine, thus complexifying pharmacological management.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patient of legal age and younger than 75 years
- Patient with a Rankin score less then or equal to 2 and with or without apathy, demonstrated by AI scales at 3 months after stroke (apathetic patient...
- Affiliate or beneficiary of a social security scheme
- people (female study people and female partners of male participants) using highly effective contraceptive methods (intra-uterine device, progestin...
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination...
You likely can't join if
- Patients over 75 years old
- Taking of any pharmacological treatment likely to affect cholinergic systems at the time of PET-scan: Amitriptyline, Atropine, Brompheniramine...
- Taking of any pharmacological treatment likely to affect 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)
- NYHA Class III to IV Heart Failure Patient
See the full eligibility criteria
- Patient of legal age and younger than 75 years
- Patient with a Rankin score less then or equal to 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
- people (female study people 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
- Taking of any pharmacological treatment likely to affect cholinergic systems at the time of PET-scan: Amitriptyline, Atropine, Brompheniramine, Chlorphenamine, Chlorpromazine, Clomipramine, Clozapine, Dimenhydrinate...
- Taking of any pharmacological treatment likely to affect 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)
- NYHA Class III to IV Heart Failure Patient
- Patients with allergy or conter-indication to entacapone
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
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 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.