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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
neuropsychological assessment
biological sample
medical imagery
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Parkinson Disease focused on measuring serotonergic 5-HT4 receptor, radiotracer

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pet scan with the specific radioligand [11C]SB207145

Arm Description

The following examen are added by the study : neuropsychologic consultation PET scan MRI biological sample Questionnaires

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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
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
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
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)
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)

Full Information

First Posted
April 12, 2023
Last Updated
September 26, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05916625
Brief Title
Exploratory Study of the Expression of the Serotonergic 5-HT4 Receptor in Parkinson's Disease
Acronym
PARK 5-HT4
Official Title
Exploratory Study of the Expression of the Serotonergic 5-HT4 Receptor in Parkinson's
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
serotonergic 5-HT4 receptor, radiotracer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pet scan with the specific radioligand [11C]SB207145
Arm Type
Experimental
Arm Description
The following examen are added by the study : neuropsychologic consultation PET scan MRI biological sample Questionnaires
Intervention Type
Other
Intervention Name(s)
neuropsychological assessment
Intervention Description
a consultation to assess cognitive and psycho-behavioral functions with questionnaires
Intervention Type
Other
Intervention Name(s)
biological sample
Intervention Description
10 mL intravenous whole blood collection in EDTA tube
Intervention Type
Procedure
Intervention Name(s)
medical imagery
Intervention Description
Pet scan with the specific radioligand [11C]SB207145 and MRI
Primary Outcome Measure Information:
Title
Comparison of the expression of the 5-HT4 receptor between patients with mild to moderate Parkinson's disease to age-matched healthy controls
Description
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).
Time Frame
During MRI procedure
Secondary Outcome Measure Information:
Title
Description of 5-HT4 alterations related to motor symptoms
Description
Relationship between the level of expression of the tracer and the clinical scores on the motor questionnaires
Time Frame
During MRI procedure
Title
Description of 5-HT4 alterations related to non-motor symptoms
Description
Relationship between the level of expression of the tracer and the clinical scores on the non-motor questionnaires
Time Frame
During MRI procedure
Title
Description of 5-HT4 alterations related to cognitive symptoms
Description
Relationship between the level of expression of the tracer and the clinical scores on the cognitive questionnaires
Time Frame
During MRI procedure
Title
Description of 5-HT4 alterations related to psychobehavioral symptoms
Description
Relationship between the level of expression of the tracer and the clinical scores on the psychobehavioral questionnaires
Time Frame
During MRI procedure
Title
Description of 5-HT4 alterations related to SERT polymorphism data
Description
Relationship between the level of expression of the tracer and SERT polymorphism data (5-HTTLPR polymorphism, evaluated as presence/absence)
Time Frame
During MRI procedure
Title
Description of 5-HT4 alterations related to BDNF polymorphism data
Description
Relationship between the level of expression of the tracer and BDNF polymorphism data (Val66Met rs6265 polymorphism, evaluated as presence/absence)
Time Frame
During MRI procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing XIE
Phone
04 72 43 20 44
Email
jing.xie@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing XIE
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CERMEP
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing XIE
First Name & Middle Initial & Last Name & Degree
Jing XIE
Facility Name
Hôpital des Charpennes Centre de Recherche Clinique "Vieillissement-Cerveau-Fragilité"
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing XIE, PH
First Name & Middle Initial & Last Name & Degree
Jing XIE

12. IPD Sharing Statement

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

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