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

Civil Hospices of Lyon

Status

Completed

Conditions

Parkinson Disease

Treatments

Procedure: medical imagery

Other: neuropsychological assessment

Other: biological sample

Study type

Interventional

Funder types

Other

Identifiers

NCT05916625

69HCL22_0953

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

50 to 85 years old

Volunteers

Accepts Healthy Volunteers

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)