In Vivo Involvement of the Cholinergic and Dopaminergic Systems in the Pathophysiology of Apathy.
NCT ID: NCT03998852
Last Updated: 2021-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
30 participants
INTERVENTIONAL
2021-04-13
2022-05-13
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Molecular imaging
Positron Emission Tomography (PET) molecular imaging of dopaminergic and cholinergic systems using two radiotracers
Positron Emission Tomography (PET) with [18F]-FDOPA
Positron Emission Tomography (PET) with \[18F\]-FDOPA
Positron Emission Tomography (PET) with [18F]-FEOBV
Positron Emission Tomography (PET) with \[18F\]-FEOBV
Magnetic Resonnance Imaging (MRI)
MRI protocol will be performed on the same day that the \[18F\]-FEOBV PET imaging, using a 3T scanner (Philips Medical System). Different types of images will be acquired.
Neuropsychological evaluation
Neuropsychological evaluation will be performed, consisting in an assessment of apathy by actigraphy (social or physical activities will be recorded during seven days) and a complementary assessment of apathy using the Lille Apathy Rating Scale (LARS)
Interventions
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Positron Emission Tomography (PET) with [18F]-FDOPA
Positron Emission Tomography (PET) with \[18F\]-FDOPA
Positron Emission Tomography (PET) with [18F]-FEOBV
Positron Emission Tomography (PET) with \[18F\]-FEOBV
Magnetic Resonnance Imaging (MRI)
MRI protocol will be performed on the same day that the \[18F\]-FEOBV PET imaging, using a 3T scanner (Philips Medical System). Different types of images will be acquired.
Neuropsychological evaluation
Neuropsychological evaluation will be performed, consisting in an assessment of apathy by actigraphy (social or physical activities will be recorded during seven days) and a complementary assessment of apathy using the Lille Apathy Rating Scale (LARS)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Locations
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Bordeaux University Hospital
Bordeaux, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHUBX 2017/22
Identifier Type: -
Identifier Source: org_study_id
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