2022-503089-57-00CompletedPhase 2/3
Exploratory study of the expression of the serotonergic 5-HT4 receptor in Parkinson's disease
Source: EU CTIS (euclinicaltrials.eu) · Last updated 22 May 2024
Brief summary (registry, in English)
The main objective is to compare the expression of the 5-HT4 receptor in patients with mild to moderate Parkinson's disease compared to age-matched healthy controls (controls)
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 11 May 2023
- Start date
- 18 Sept 2023
- Lead sponsor
- Hospices Civils De Lyon
- Diseases
- Parkinson disease
- EU CT number
- 2022-503089-57-00
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 35
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) 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)
Other
- 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
- Contraindication to magnetic resonance imaging (MRI) or positron emission tomography (PET)
- Exceeding the annual amount of compensation authorized for participation in research protocols
Who the study is looking for
- 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 (for patient only)
- Duration of disease progression between 2 and 8 years (for patient only)
- MoCA ≥ 20/30 (for patient only)
- Age between ≥ 50 and ≤ 85 years old
- if woman , postmenopausal woman
- Affiliated to a social security scheme or similar
- Having given their written consent to participate
- Level of study: ≥ 6 years of schooling
- No history of neurological or psychiatric disease (healthy volunteers only)
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CERMEP - imagerie du vivant | BRON cedex | France | Completed |
| Hospices Civils De Lyon | Villeurbanne | France | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.