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NCT05916625Completed

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

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

Source: ClinicalTrials.gov · Last updated 7 Oct 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
40 (actual)
First submitted
12 Apr 2023
Start date
7 Dec 2023
Primary completion date
29 Sept 2025
Lead sponsor
Hospices Civils de Lyon
NCT number
NCT05916625

What you commit to

  • Study type: Interventional
  • Participants enrolled: 40
  • From 7 Dec 2023 to the primary completion date, 29 Sept 2025
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • Diagnosis other than Parkinson's disease ( for patient only)
  • Cognitive impairment (MOCA score ≤26) (for healthy volunteers only)
  • Current or past neurological or psychiatric pathology (for healthy volunteers only)
  • 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)

Other

  • Contraindication to magnetic resonance imaging (MRI) or positron emission tomography (PET)
  • 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)
  • Serious and progressive medical pathology

Who the study is looking for

  • 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.

Age in the registry: 50 years to 85 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CERMEP
Coordinator of this site? Confirm its status
BronFranceUnknown status
Hôpital des Charpennes Centre de Recherche Clinique "Vieillissement-Cerveau-Fragilité"
Coordinator of this site? Confirm its status
LyonFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.