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Multiple System Atrophy | Investigation of the Serotoninergic System in Multiple System Atrophy: a Positron Emission Tomography (PET) Study

Multiple System Atrophy research study

What is the primary objective of this study?

Multiple system atrophy (MSA) is a sporadic neurodegenerative disorder of the adult associated to a poor prognosis. MSA is clinically characterized by the association of extra-pyramidal, dysautonomic, cerebellar and pyramidal symptoms. Histological and biological studies have raised the hypothesis that, beside the well known dopamine deficiency, some of the symptoms could be related to a dysfunction in serotoninergic neurotransmission. Serotonin is involved in the modulation of several functions impaired in MSA, such as mood, motricity or sleep. The recent description of an association between loss of brainstem serotonin neurons and sudden death in patients with MSA reinforced the hypothesis of a critical role played by this neurotransmitter in the pathophysiology of this disease. Autoreceptors called 5-HT1a are strongly involved in the regulation of serotonin neurotransmission. During the last years several radio-ligands allowing in vivo PET quantification of 5-HT1a receptors, such as 18F-MPPF (4-(2'-methoxyphenyl)-1-[2'-(N-2''-piridinyl)-p-fluorobenzamide]methylpiperazine), were developed. Moreover, the investigators recently demonstrated the ability of this brain functional imaging method to investigate, in healthy volunteers, the functional properties of 5-HT1a autoreceptors through an evaluation of their desensitization after a single oral dose of fluoxetine.

Who is eligible to participate?

Inclusion Criteria: - Patients with Multiple system atrophy (MSA) - MSA possible or probable - Male and female - Age : 30 to 80 - No cognitive impairment - Unmodified treatment for 2 months - Able to give informed consent - Affiliated to social insurance - Patients with idiopathic Parkinson's disease (IPD): - Positive clinical criteria for IPD - Male and female - Age : 30 to 80 - No cognitive impairment - Unmodified treatment for 2 months - Able to give informed consent - Affiliated to social insurance - Healthy controls: - Absence of neuropsychiatric disorder - Male and female - Age : 30 to 80 - Able to give informed consent - Affiliated to social insurance Exclusion Criteria: - Patients with Multiple system atrophy (MSA) - Other Parkinsonian syndrome - Dementia - Recent intake (< 4 weeks or 8 weeks for fluoxetine) of medication acting on 5-HT1a receptors - History of major depression - Contraindication to brain MRI - Contraindication to PET - Patients with idiopathic Parkinson's disease - Other Parkinsonian syndrome - Dementia - Recent intake (< 4 weeks or 8 weeks for fluoxetine) of medication acting on 5-HT1a receptors - History of major depression - Contraindication to brain MRI - Contraindication to PET - Healthy controls: - Patient having a neuropsychiatric disease - Recent intake (< 4 weeks or 8 weeks for fluoxetine) of medication acting on 5-HT1a receptors - History of major depression - Contraindication to brain MRI - Contraindication to PET

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Multiple System Atrophy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Radiation:PET (Positron Emission Tomography) Study5-HT1a auto-receptors will be visualized in vivo using 18F-MPPF PET study. Two PET studies will be performed, one after the intake of a single oral dose of fluoxetine and the other after placebo. The order of fluoxetine and placebo intake will be randomly assigned.

Other:Brain MRI (magnetic resonance imaging)A brain MRI (magnetic resonance imaging)will be performed the day of the first PET study.

Drug:Fluox├ętine / PlaceboThe two PET studies will be performed, one after the intake of a single oral dose of fluoxetine and the other after placebo. The order of fluoxetine and placebo intake will be randomly assigned.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Multiple system atrophy

Idiopathic Parkinson Disease

Volunteers without neuropsychiatric disorder (Control)

Study Status

Completed

Start Date: April 2010

Completed Date: March 2016

Phase:

Type: Observational

Design:

Primary Outcome: 18F-MPPF binding potential - Biding potential (BP) under placebo in the raphe nucleus

Secondary Outcome: 18F-MPPF binding potential - Biding potential (BP) in other brain areas

Study sponsors, principal investigator, and references

Principal Investigator: Igor SIBON, Pr

Lead Sponsor: University Hospital, Bordeaux

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01136213

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