A look at how cholinergic and dopaminergic systems may contribute to apathy after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial uses PET imaging to measure cholinergic and dopaminergic function in people who have had a stroke and show apathy. It combines [18F]-FDOPA PET for dopamine-related activity and [18F]-FEOBV PET for cholinergic system activity, along with MRI and neuropsychological assessments. The goal is to better characterize the neurochemical substrates of apathy as a syndrome and to relate these findings to clinical features. The study is conducted at Bordeaux University Hospital, with strict inclusion and exclusion criteria to identify appropriate participants. Imaging results may inform future approaches to managing post-stroke apathy.

Why it matters

Who can join: the full rules

Inclusion 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
* 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)

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, Hydroxyzine.
* 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
* 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

Where it's running

• Bordeaux University Hospital
  Bordeaux, France Recruiting

Study contacts

• Study coordinator: Nicolas BALAMOUTOFF
• Email: nicolas.balamoutoff@chu-bordeaux.fr
• Phone: 05 56 79 55 40

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.