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

Parkinson Disease Clinical Trial

— PARK 5-HT4  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05916625
• Other study ID #: 69HCL22_0953
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2023
• Source: Hospices Civils de Lyon
• Contact: Jing XIE
• Phone: 04 72 43 20 44
• Email: jing.xie[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• neuropsychological assessment
a consultation to assess cognitive and psycho-behavioral functions with questionnaires
• biological sample
10 mL intravenous whole blood collection in EDTA tube

Procedure:
• medical imagery
Pet scan with the specific radioligand [11C]SB207145 and MRI

Locations

Country	Name	City	State
France	CERMEP	Bron
France	Hôpital des Charpennes Centre de Recherche Clinique "Vieillissement-Cerveau-Fragilité"	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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