NCT03998852

In Vivo Involvement of the Cholinergic and Dopaminergic Systems in the Pathophysiology of Apathy.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Apathy

Interventions

Type	Name	Description
DRUG	Positron Emission Tomography (PET) with [18F]-FDOPA	Positron Emission Tomography (PET) with \[18F\]-FDOPA
DRUG	Positron Emission Tomography (PET) with [18F]-FEOBV	Positron Emission Tomography (PET) with \[18F\]-FEOBV
DEVICE	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.
OTHER	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)

Timeline

• Start date: 2021-04-13
• Primary completion: 2022-04-13
• Completion: 2022-05-13
• First posted: 2019-06-26
• Last updated: 2021-06-01

Locations

1 site across 1 country: France