Investigation of the Serotoninergic System in Multiple System Atrophy: a Positron Emission Tomogr… (NCT01136213) | Clinical Trial Compass
CompletedNot Applicable
Investigation of the Serotoninergic System in Multiple System Atrophy: a Positron Emission Tomography (PET) Study
France53 participantsStarted 2010-04
Plain-language summary
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 can participate
Age range
30 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
18F-MPPF binding potential - Biding potential (BP) under placebo in the raphe nucleus