Exploratory Study of the Expression of the Serotonergic 5-HT4 Receptor in Parkinson's Disease
NCT ID: NCT05916625
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2023-12-07
2025-09-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Pet scan with the specific radioligand [11C]SB207145
The following examen are added by the study :
neuropsychologic consultation PET scan MRI biological sample Questionnaires
neuropsychological assessment
a consultation to assess cognitive and psycho-behavioral functions with questionnaires
biological sample
10 mL intravenous whole blood collection in EDTA tube
medical imagery
Pet scan with the specific radioligand \[11C\]SB207145 and MRI
Interventions
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neuropsychological assessment
a consultation to assess cognitive and psycho-behavioral functions with questionnaires
biological sample
10 mL intravenous whole blood collection in EDTA tube
medical imagery
Pet scan with the specific radioligand \[11C\]SB207145 and MRI
Eligibility Criteria
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Inclusion Criteria
* For women: postmenopausal
* Affiliated to a social security scheme or similar;
* Having given written consent to participate in the free and informed study.
* Level of study: ≥ 6 years of schooling
* only for healthy volunteer : No history of neurological or psychiatric disease
* Only for patient : Having a clinically established or probable diagnosis of Parkinson's disease according to the criteria defined by the Movement Disorder Society at a Hoehn and Yahr stage ≤ 3 (in on dopa conditions) and a duration of evolution of the disease between 2 and 8 years.
* Only for patient : Having a MoCA (Montreal Cognitive Assessment) ≥ 20/30.
Exclusion Criteria
* Treated with specific serotonin inhibitors (SSRIs), specific noradrenaline inhibitors (SNRIs), tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs) and neuroleptics in the last 3 months
* Use of recreational drugs interfering with the serotonergic system (ecstasy, MDMA) or opioids (cannabis, opiates) in the last 3 months or chronic use
* Contraindication to magnetic resonance imaging (MRI) or positron emission tomography (PET)
* Participation in the last year to a study using ionizing radiation or concomitant participation in another research project involving the human being that may interfere with the results or the conclusions of this study
* Exceeding the annual amount of compensation authorized for participation in research protocols
* Deprivation of liberty by judicial or administrative decision, person subject to a legal protection measure
* BMI ≥ 35kg/m2
* Presence of depression (BDI-2 score ≥21), anxiety (Parkinson Anxiety Scale (PAS) score ≥14) or apathy (STARKSTEIN score ≥14) - (for healthy volunteers only)
* Cognitive impairment (MOCA score ≤26) (for healthy volunteers only)
* Current or past neurological or psychiatric pathology (for healthy volunteers only)
* Serious and progressive medical pathology
* Current or past dependence on any addictive substance according to DSM-V (The Diagnostic and Statistical Manual of Mental Disorders) criteria (alcohol, cannabis, hallucinogens, inhalants, opiates, sedatives, stimulants), except tobacco and caffeine. (for healthy volunteers only)
50 Years
85 Years
ALL
Yes
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Jing XIE
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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CERMEP
Bron, , France
Hôpital des Charpennes Centre de Recherche Clinique "Vieillissement-Cerveau-Fragilité"
Lyon, , France
Countries
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Other Identifiers
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69HCL22_0953
Identifier Type: -
Identifier Source: org_study_id
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