Exploratory study of the expression of the serotonergic 5-HT4 receptor in Parkinson's disease

Phase 1

Recruiting

• Conditions: Parkinson disease; Therapeutic area: Phenomena and Processes [G] - Musculoskeletal and Neural Physiological Phenomena [G11]

• Registration Number: CTIS2022-503089-57-00
• Lead Sponsor: Hospices Civils De Lyon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-11
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

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 (for patient only), Duration of disease progression between 2 and 8 years (for patient only), MoCA = 20/30 (for patient only), Age between = 50 and = 85 years old, if woman , postmenopausal woman, Affiliated to a social security scheme or similar, Having given their written consent to participate, Level of study: = 6 years of schooling, No history of neurological or psychiatric disease (healthy volunteers only)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to compare the expression of the 5-HT4 receptor in patients with mild to moderate Parkinson's disease compared to age-matched healthy controls (controls);Secondary Objective: describe 5-HT4 alterations related to motor, non-motor, cognitive and psychobehavioral symptoms and polymorphism data, describe 5-HT4 alterations in relation to polymorphism data.;Primary end point(s): the difference in binding of the radiotracer [11C]SB207145 to the 5-HT4 receptor between Parkinsonian patients and control subjects. For each subject, the specific binding of the tracer will be calculated for each voxel with respect to a reference zone (the white matter of the cerebellum).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):the description of the relationship between the level of expression of the tracer and the clinical scores on the scales of motor, non-motor, cognitive and psycho-behavioural symptoms.;Secondary end point(s):the description of the relationship between the expression level of the tracer and the polymorphism data.