Clinical trial NCT05916625: Exploratory Study of the Expression of the Serotonergic 5-HT4 Receptor in Parkinson's Disease
Official title: Exploratory Study of the Expression of the Serotonergic 5-HT4 Receptor in Parkinson's
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: serotonergic 5-HT4 receptor
radiotracer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 35
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Comparison of the expression of the 5-HT4 receptor between patients with mild to moderate Parkinson's disease to age-matched healthy controls
timeFrame: During MRI procedure
Secondary outcomes:
measure: Description of 5-HT4 alterations related to motor symptoms
timeFrame: During MRI procedure
measure: Description of 5-HT4 alterations related to non-motor symptoms
timeFrame: During MRI procedure
measure: Description of 5-HT4 alterations related to cognitive symptoms
timeFrame: During MRI procedure
measure: Description of 5-HT4 alterations related to psychobehavioral symptoms
timeFrame: During MRI procedure
measure: Description of 5-HT4 alterations related to SERT polymorphism data
timeFrame: During MRI procedure
measure: Description of 5-HT4 alterations related to BDNF polymorphism data
timeFrame: During MRI procedure
Other outcomes:
Locations:
city: Bron
country: France
facility: CERMEP
city: Lyon
country: France
facility: Hôpital des Charpennes Centre de Recherche Clinique "Vieillissement-Cerveau-Fragilité"
Study officials:
affiliation: Hospices Civils de Lyon
name: Jing XIE
role: PRINCIPAL_INVESTIGATOR
References: