Serotonin in Impulse Control Disorders in Parkinson's Disease

NCT03970239 | Unknown DMC

• 2 other identifiers: 69HCL18_00122019-000340-99
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

Parkinson's disease; Impulse control disorders; Serotoninergic system; Positron Emission Tomography (PET)

Outcome Measures

Primary Outcomes (1)

• Difference in binding potential of [18 Fluorine]-altanserin ([18F]-altanserin) and [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) ([11C]-DASB)

  Between-group difference of binding potential of \[18 Fluorine\]-altanserin (\[18F\]-altanserin) and \[11 Carbon\]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile (\[11C\]-DASB) (\[11C\]-DASB)

  2-3 days

Secondary Outcomes (17)

• Ardouin Scale of Behavior in Parkinson's Disease (ASBPD)

  2-3 days

• Questionnaire For Impulsive-Compulsive Disorders In Parkinson's Disease-Rating Scale (QUIP-RS)

  2-3 days

• Urgency, Premeditation (lack of), Perseverance (lack of), Sensation Seeking Impulsive Behavior Scale (UPPS Impulsive Behavior Scale)

  2-3 days

• Movement Disorder Society (MDS) Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  2-3 days

• Beck Depression Inventory II (BDI-II)

  2-3 days

Study Arms (2)

Parkinson's Disease patients

EXPERIMENTAL

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.

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

Imaging of healthy volunteers

EXPERIMENTAL

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.

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

Interventions

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

Parkinson's Disease patients

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

Imaging of healthy volunteers

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Bron, France

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Disruptive, Impulse Control, and Conduct Disorders

Interventions

3-amino-4-(2-dimethylaminomethylphenylsulfanyl)benzonitrile

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders

Study Officials

• Stéphane THOBOIS, PhD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphane THOBOIS, PhD

CONTACT

4 72 35 72 18; stephane.thobois@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 31, 2019
• Study Start: May 13, 2019
• Primary Completion: February 13, 2022
• Study Completion: February 13, 2022
• Last Updated: April 8, 2020

Record last verified: 2020-02

Locations

FR (1)