Serotonin in Impulse Control Disorders in Parkinson's Disease

NCT ID: NCT03970239

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-13
• Study Completion Date: 2022-02-13

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Parkinson's Disease patients

All study participants undergo functional imaging of the serotoninergic system with Positron Emission Tomography (PET) using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin). [11C] -DASB is a highly specific PET radiotracer which binds to the serotonin transporter (SERT).

[18F]-altanserin is a highly specific PET radiotracer which specifically binds to the serotonin 5-hydroxytryptamine receptor 2A (5-HT2A) receptor.

Group Type: EXPERIMENTAL

Positron Emission Tomography using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin)

Intervention Type: DRUG

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.

Imaging of healthy volunteers

All healthy volunteers undergo functional imaging of the serotoninergic system with Positron Emission Tomography (PET) using [18F]-altanserin.

[18F]-altanserin is a highly specific PET radiotracer which specifically binds to the serotonin 5-hydroxytryptamine receptor 2A (5-HT2A) receptor.

Group Type: EXPERIMENTAL

Positron Emission Tomography using [18 Fluorine]-altanserin ([18F]-altanserin)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Group 1 Patients with Parkinson's disease and impulse control disorders

• Patients with a diagnosis of clinically established or clinically probable Parkinson's disease according to the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease
• Patients aged ≥ 30 and ≤ 80 years old
• Patients presenting currently with impulse control disorders or having presented with impulse control disorders in the last 2 years (Ardouin Behavior Scale score ≥2 for one or more of the following items: eating behavior; compulsive buying; pathological gambling; hypersexuality) , following the diagnosis of Parkinson's disease
• Patients able to sign the consent document and willing to participate in all aspects of the study

Patients with Parkinson's disease and without impulse control disorders

• Patients with a diagnosis of clinically established or clinically probable Parkinson's disease according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease
• Patients aged ≥ 30 and ≤ 80 years old
• Patients not currently presenting with impulse control disorders and other hyperdopaminergic behaviors and not having ever presented with impulse control disorders
• Patients able to sign a consent document and willing to participate in all aspects of the study

Group 2 : Healthy volunteers

Subjects aged ≥ 30 and ≤ 80 years old

• Subjects not currently presenting with impulse control disorders or hyperdopaminergic behaviors and not having ever presented with impulse control disorders
• Subjects able to sign a consent document and willing to participate in all aspects of the study

Exclusion Criteria

Group 1 :

Patients with Parkinson's disease and impulse control disorders

• Patients with Montreal Cognitive Assessment score ≤24 or Frontal Assessment Battery score ≤14
• Patients not able to perform Positron Emission Tomography (PET) or Magnetic Resonance Imaging (MRI)
• Patients presenting with other severe medical condition or other parkinsonian syndrome
• Patients treated with Deep Brain Stimulation or levodopa pump
• Patients treated with drugs or consuming recreative drugs specifically interfering with the serotoninergic, noradrenergic or opiate systems in the last 3 months
• Patients presenting with substance dependence, except for tobacco
• Patients with Body Mass Index ≥ 35kilogram/meters2 (kg/m2)

Patients with Parkinson's disease and without impulse control disorders

• Patients with Montreal Cognitive Assessment score ≤24 or Frontal Assessment Battery score ≤14
• Patients not able to perform Positron Emission Tomography or Magnetic Resonance Imaging
• Patients presenting with other severe medical condition or other parkinsonian syndrome
• Patients treated with Deep Brain Stimulationor levodopa pump
• Patients treated with drugs or consuming recreative drugs specifically interfering with the serotoninergic, noradrenergic or opiate systems in the last 3 months
• Patients presenting with substance dependence, except for tobacco
• Patients with Body Mass Index ≥35kg/m2

Group 2 : Healthy volunteers

• Subjects with Montreal Cognitive Assessment score ≤24 or Frontal Assessment Battery score ≤14
• Subjects not able to perform Positron Emission Tomography or Magnetic Resonance Imaging
• Subjects presenting with neurologic, psychiatric or other severe medical condition
• Subjects treated with drugs or consuming recreative drugs specifically interfering with the serotoninergic, noradrenergic or opiate systems in the last 3 months
• Subjects presenting with substance dependence, except for tobacco
• Subjects with Body Mass Index ≥35kg/m2

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphane THOBOIS, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hospices Civils de Lyon

Bron, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Stéphane THOBOIS, PhD

Role: CONTACT

stephane.thobois@chu-lyon.fr

4 72 35 72 18 ext. 33

Facility Contacts

THOBOIS STEPHANE

Role: primary

Other Identifiers

2019-000340-99

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

69HCL18_0012

Identifier Type: -

Identifier Source: org_study_id