Exploring the 5-HT4 receptor in Parkinson's disease
Exploratory Study of the Expression of the Serotonergic 5-HT4 Receptor in Parkinson's
This study is trying to see how the 5-HT4 receptor works in people with moderate Parkinson's disease and how it affects their movement, thinking, and feelings compared to those without the condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Bron and 1 other locations) |
| Trial ID | NCT05916625 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the expression of the serotonergic 5-HT4 receptor in patients with moderate Parkinson's disease using positron emission tomography (PET) imaging. It will compare motor, cognitive, and affective changes in these patients to control subjects. Additionally, the study will assess the impact of specific genetic polymorphisms on the receptor's expression. Participants will undergo neuropsychological assessments, biological sampling, and medical imaging as part of the evaluation.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 to 85 with a clinically established diagnosis of Parkinson's disease at Hoehn and Yahr stage ≤ 3.
Not a fit: Patients with other neurological or psychiatric disorders or those treated with specific serotonin inhibitors in the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could enhance understanding of Parkinson's disease and lead to improved treatment strategies targeting the serotonergic system.
How similar studies have performed: While the exploration of serotonergic receptors in Parkinson's disease is ongoing, this specific approach using PET imaging and genetic analysis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Bron and 1 other locations
- Cermep — Bron, France (Recruiting)
- Hôpital des Charpennes Centre de Recherche Clinique "Vieillissement-Cerveau-Fragilité" — Lyon, France (Recruiting)
Study contacts
- Principal investigator: Jing XIE — Hospices Civils de Lyon
- Study coordinator: Jing XIE
- Email: jing.xie@chu-lyon.fr
- Phone: 04 72 43 20 44
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.