Exploratory Study of the Expression of the Serotonergic 5-HT4 Receptor in Parkinson's Disease (PARK 5-HT4)

Exploratory Study of the Expression of the Serotonergic 5-HT4 Receptor in Parkinson's

The research aim to study in detail the motor, cognitive and affective modifications of Parkinsonian patients (compared to control subjects) at a moderate stage of the disease and to analyze by positron emission tomography (PET) imaging with the specific radioligand [11C]SB207145 the expression levels of this 5-HT4 receptor. At the same time, the study will monitor the impact of the 5-HTTLPR polymorphisms of Serotonin Transporter (SERT) and Brain-derived neurotrophic factor (BDNF) Val66Met on the expression of the 5-HT4 receptor in subjects.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: neuropsychological assessment; Other: biological sample; Procedure: medical imagery

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • CERMEP
  • Lyon, France
    • Hôpital des Charpennes Centre de Recherche Clinique "Vieillissement-Cerveau-Fragilité"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Man or woman : Age between ≥ 50 and ≤ 85 years old
• 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:

• Diagnosis other than Parkinson's disease ( for patient only)
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pet scan with the specific radioligand [11C]SB207145; The following examen are added by the study : neuropsychologic consultation PET scan MRI biological sample Questionnaires	Other: neuropsychological assessment; a consultation to assess cognitive and psycho-behavioral functions with questionnaires; Other: biological sample; 10 mL intravenous whole blood collection in EDTA tube; Procedure: medical imagery; Pet scan with the specific radioligand [11C]SB207145 and MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the expression of the 5-HT4 receptor between patients with mild to moderate Parkinson's disease to age-matched healthy controls	difference in the tracer [11C]SB207145 's binding, the specific binding of the tracer will be calculated for each voxel with respect to a reference zone (the white matter of the cerebellum).	During MRI procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of 5-HT4 alterations related to motor symptoms	Relationship between the level of expression of the tracer and the clinical scores on the motor questionnaires	During MRI procedure
Description of 5-HT4 alterations related to non-motor symptoms	Relationship between the level of expression of the tracer and the clinical scores on the non-motor questionnaires	During MRI procedure
Description of 5-HT4 alterations related to cognitive symptoms	Relationship between the level of expression of the tracer and the clinical scores on the cognitive questionnaires	During MRI procedure
Description of 5-HT4 alterations related to psychobehavioral symptoms	Relationship between the level of expression of the tracer and the clinical scores on the psychobehavioral questionnaires	During MRI procedure
Description of 5-HT4 alterations related to SERT polymorphism data	Relationship between the level of expression of the tracer and SERT polymorphism data (5-HTTLPR polymorphism, evaluated as presence/absence)	During MRI procedure
Description of 5-HT4 alterations related to BDNF polymorphism data	Relationship between the level of expression of the tracer and BDNF polymorphism data (Val66Met rs6265 polymorphism, evaluated as presence/absence)	During MRI procedure

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Jing XIE, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2023
• Primary Completion (Actual): September 29, 2025
• Study Completion (Actual): September 29, 2025

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: radiotracer; serotonergic 5-HT4 receptor
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease; Behavioral Disciplines and Activities; Psychological Tests; Neuropsychological Tests
• Other Study ID Numbers: 69HCL22_0953

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No