MedTrace Logo

Serotonin in Impulse Control Disorders in Parkinson's Disease

NCT03970239 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-04-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Stéphane THOBOIS, PhD · Hospices Civils de Lyon

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-13
Primary Completion
2022-02-13
Completion
2022-02-13

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03970239 on ClinicalTrials.gov