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Parkinson DiseasePARK 5-HT4NCT05916625

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

A study testing neuropsychological assessment, biological sample and medical imagery in people with Parkinson Disease, run by Hospices Civils de Lyon at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 50 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Parkinson Disease
What is being tested?
neuropsychological assessment, biological sample and medical imagery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesFrance
Study dates
7 Dec 2023to 29 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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)

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CERMEP

    Bron, 69500

  • Hôpital des Charpennes Centre de Recherche Clinique "Vieillissement-Cerveau-Fragilité"

    Lyon

Other trials in France

About this study

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

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.

Being tested
neuropsychological assessment, biological sample, medical imagery
Keywords
serotonergic 5-HT4 receptor, radiotracer
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • neuropsychological assessmentOther

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

  • biological sampleOther

    10 mL intravenous whole blood collection in EDTA tube

  • medical imageryProcedure or surgery

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

Study groups in NCT05916625
Study groupRoleWhat they receive
Pet scan with the specific radioligand [11C]SB207145ExperimentalThe following examen are added by the study : neuropsychologic consultation PET scan MRI biological sample Questionnaires
Receives: Other: neuropsychological assessment; Other: biological sample; Procedure: medical imagery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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).

    Measured: During MRI procedure

Secondary outcomes (6)

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

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

    Measured: During MRI procedure

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

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

    Measured: During MRI procedure

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

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

    Measured: During MRI procedure

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

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

    Measured: During MRI procedure

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

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

    Measured: During MRI procedure

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

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

    Measured: During MRI procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2023
  2. Study start7 Dec 2023
  3. Primary completion29 Sep 2025
  4. Study completion29 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05916625
Sponsor's protocol ID
69HCL22_0953
Acronym
PARK 5-HT4
Status last verified
Oct 2025
First submitted
12 Apr 2023
Last updated
7 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing neuropsychological assessment, biological sample and medical imagery in people with Parkinson Disease, run by Hospices Civils de Lyon at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05916625.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.

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