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Completed

NCT Number: NCT05916625

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

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CERMEP, Bron, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Neuropsychological assessment

Other

a consultation to assess cognitive and psycho-behavioral functions with questionnaires

Biological sample

Other

10 mL intravenous whole blood collection in EDTA tube

medical imagery

Procedure

Pet scan with the specific radioligand [11C]SB207145 and MRI

Primary outcomes

  1. Comparison of the expression of the 5-HT4 receptor between patients with mild to moderate Parkinson's disease to age-matched healthy controls

    Time frame: During MRI procedure

    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).

Secondary outcomes

  1. Description of 5-HT4 alterations related to motor symptoms

    Time frame: During MRI procedure

    Relationship between the level of expression of the tracer and the clinical scores on the motor questionnaires

  2. Description of 5-HT4 alterations related to non-motor symptoms

    Time frame: During MRI procedure

    Relationship between the level of expression of the tracer and the clinical scores on the non-motor questionnaires

  3. Description of 5-HT4 alterations related to cognitive symptoms

    Time frame: During MRI procedure

    Relationship between the level of expression of the tracer and the clinical scores on the cognitive questionnaires

  4. Description of 5-HT4 alterations related to psychobehavioral symptoms

    Time frame: During MRI procedure

    Relationship between the level of expression of the tracer and the clinical scores on the psychobehavioral questionnaires

  5. Description of 5-HT4 alterations related to SERT polymorphism data

    Time frame: During MRI procedure

    Relationship between the level of expression of the tracer and SERT polymorphism data (5-HTTLPR polymorphism, evaluated as presence/absence)

  6. Description of 5-HT4 alterations related to BDNF polymorphism data

    Time frame: During MRI procedure

    Relationship between the level of expression of the tracer and BDNF polymorphism data (Val66Met rs6265 polymorphism, evaluated as presence/absence)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: PARK 5-HT4

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 23, 2023
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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