NCT03998852RecruitingPhase 3
In Vivo Involvement of the Cholinergic and Dopaminergic Systems in the Pathophysiology of Apathy.
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
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. Post-stroke apathy (PSA) can provide a proper in vivo model to study the underlying neurochemical substrates of apathy as a syndrome. The present project aims to provide a better characterization of the cholinergic and dopaminergic functioning in apathy as a syndrome. In order to precise the respective alterations of these two systems, investigators will use a positron emission tomography (PET) molecular imaging of dopaminergic (with \[18F\]-FDOPA, a marker of the decarboxylating enzyme of dopamine) and - for the first time in apathetic patients - cholinergic (with \[18F\]-FEOBV, a marker of the vesicular acetylcholine transporter) transmissions in 15 apathetic and 15 unapathetic patients 3 months after stroke, without overlapping depression. This dual imaging study may provide help in guiding therapeutic management of PSA. The functional network analysis allowed by functional MRI is crucial to complement regional neurotransmitter deficits observed with PET. Altogether, a multimodal approach in apathy, combining PET and MRI, can allow identifying which circuits of the cortico-striato-thalamo-cortical loops are disrupted and how these circuits are modulated by other neurotransmitters.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 20 Jun 2019
- Start date
- 13 Apr 2021
- Primary completion date
- 13 Apr 2027
- Lead sponsor
- University Hospital, Bordeaux
- Diseases
- Stroke
- NCT number
- NCT03998852
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 30
- From 13 Apr 2021 to the primary completion date, 13 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking of any selective serotonine reuptake inhibitors treatment
- Patient who underwent a PET examination in the previous month
Other illness
- NYHA Class III to IV Heart Failure Patient
- Patients with allergy or conter-indication to entacapone
- 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 TEP with \[18F\]-FEOBV or \[18F\]-FDOPA (known allergy)
Age
- Patients over 75 years old
Other
- 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
- White matter T2 hyperintense lesions (Fazekas score \> 3)
- 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 presenting a counter-indication for MRI
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bordeaux University Hospital Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.