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

NCT05916625 | Completed

• 1 other identifier: 69HCL22_0953
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

serotonergic 5-HT4 receptor; radiotracer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Description of 5-HT4 alterations related to motor symptoms

  During MRI procedure

• Description of 5-HT4 alterations related to non-motor symptoms

  During MRI procedure

• Description of 5-HT4 alterations related to cognitive symptoms

  During MRI procedure

• Description of 5-HT4 alterations related to psychobehavioral symptoms

  During MRI procedure

• Description of 5-HT4 alterations related to SERT polymorphism data

  During MRI procedure

Study Arms (1)

Pet scan with the specific radioligand [11C]SB207145

EXPERIMENTAL

The following examen are added by the study : neuropsychologic consultation PET scan MRI biological sample Questionnaires

Other: neuropsychological assessment; Other: biological sample; Procedure: medical imagery

Interventions

neuropsychological assessment OTHER

a consultation to assess cognitive and psycho-behavioral functions with questionnaires

Pet scan with the specific radioligand [11C]SB207145

biological sample OTHER

10 mL intravenous whole blood collection in EDTA tube

Pet scan with the specific radioligand [11C]SB207145

medical imagery PROCEDURE

Pet scan with the specific radioligand \[11C\]SB207145 and MRI

Pet scan with the specific radioligand [11C]SB207145

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

CERMEP

Bron, 69500, France

Location

Hôpital des Charpennes Centre de Recherche Clinique "Vieillissement-Cerveau-Fragilité"

Lyon, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Jing XIE

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: June 23, 2023
• Study Start: December 7, 2023
• Primary Completion: September 29, 2025
• Study Completion: September 29, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-10

Locations

FR (2)