NCT03970239

Serotonin in Impulse Control Disorders in Parkinson's Disease

Role of the Serotoninergic System in Impulse Control Disorders in Parkinson's Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Impulse control disorders are frequent and troublesome in patients with Parkinson's disease. However, the cerebral functional alterations related to impulse control disorders in Parkinson's disease are poorly understood and may involve the serotoninergic system besides alterations in the dopaminergic system. The primary objective of this study is to investigate the cerebral functional alterations in the serotoninergic system in patients with Parkinson's disease and impulse control disorders using Positron Emission Tomography with highly specific radiotracers of serotonin transporter (SERT) using \[11 Carbon\]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile (\[11C\]-DASB) and of serotonin 5-Hydroxytryptamine 2A (5-HT2A) receptor using \[18 Fluorine\]-altanserin (\[18F\]-altanserin), in comparison to patients with Parkinson's disease without impulse control disorders and healthy volunteers.

Conditions

• Parkinson Disease
• Impulse Control Disorders

Interventions

Type	Name	Description
DRUG	Positron Emission Tomography using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin)	Imaging of the serotoninergic system with Positron Emission Tomography using \[11 Carbon\]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile (\[11C\]-DASB) and \[18 Fluorine\]-altanserin (\[18F\]-altanserin). During this study, subjects will receive a single intravenous administration of approximately 4 Megabecquerel/kilogram (MBq/kg) of \[11C\]-DASB immediately prior to imaging using Positron Emission Tomography (PET). The effective dose in human body is about 2.1 milliSievert (mSv). On a separate day, subjects will receive a single intravenous administration of approximately 3.7 MBq/kg of \[18F\]-altanserin for 120 minutes prior to imaging using Positron Emission Tomography (PET). The effective dose in human body is about 8.4 mSv.
DRUG	Positron Emission Tomography using [18 Fluorine]-altanserin ([18F]-altanserin)	Imaging of the serotoninergic system with Positron Emission Tomography using \[18 Fluorine\]-altanserin (\[18F\]-altanserin). During this study, subjects will receive a single intravenous administration of approximately 3.7 Megabecquerel/kilogram (MBq/kg) of \[18F\]-altanserin 120 minutes prior to imaging using Positron Emission Tomography. The effective dose in human body is about 8.4 mSv.

Timeline

• Start date: 2019-05-13
• Primary completion: 2022-02-13
• Completion: 2022-02-13
• First posted: 2019-05-31
• Last updated: 2020-04-08

Locations

1 site across 1 country: France