Exploratory study of the expression of the serotonergic 5-HT4 receptor in Parkinson's disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospices Civils De Lyon

Participant type

Healthy volunteers, Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Musculoskeletal and Neural Physiological Phenomena [G11]

Trial duration

18 Sep 2023 → ongoing

Decision date (initial)

2023-08-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

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)

Secondary objectives 2

1. describe 5-HT4 alterations related to motor, non-motor, cognitive and psychobehavioral symptoms and polymorphism data
2. describe 5-HT4 alterations in relation to polymorphism data.

Conditions and MedDRA coding

Parkinson disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 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)
2. Duration of disease progression between 2 and 8 years (for patient only)
3. MoCA ≥ 20/30 (for patient only)
4. Age between ≥ 50 and ≤ 85 years old
5. if woman , postmenopausal woman
6. Affiliated to a social security scheme or similar
7. Having given their written consent to participate
8. Level of study: ≥ 6 years of schooling
9. No history of neurological or psychiatric disease (healthy volunteers only)

Exclusion criteria 12

1. Diagnosis other than Parkinson's disease ( for patient only)
2. Cognitive impairment (MOCA score ≤26) (for healthy volunteers only)
3. Current or past neurological or psychiatric pathology (for healthy volunteers only)
4. Serious and progressive medical pathology
5. Treated with specific serotonin inhibitors (SSRIs), specific noradrenaline inhibitors (SNRIs), tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs) and neuroleptics in the last 3 months
6. Use of recreational drugs interfering with the serotonergic system (ecstasy, MDMA) or opioids (cannabis, opiates) in the last 3 months or chronic use
7. Contraindication to magnetic resonance imaging (MRI) or positron emission tomography (PET)
8. 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
9. Exceeding the annual amount of compensation authorized for participation in research protocols
10. Deprivation of liberty by judicial or administrative decision, person subject to a legal protection measure
11. BMI ≥ 35kg/m2
12. Presence of depression (BDI-2 score ≥21), anxiety (Parkinson Anxiety Scale, PAS score ≥14) or apathy (STARKSTEIN score ≥14) - for healthy volunteers only

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. the difference in binding of the radiotracer [11C]SB207145 to the 5-HT4 receptor between Parkinsonian patients and control subjects. For each subject, 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 endpoints 2

1. the description of the relationship between the level of expression of the tracer and the clinical scores on the scales of motor, non-motor, cognitive and psycho-behavioural symptoms.
2. the description of the relationship between the expression level of the tracer and the polymorphism data.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospices Civils De Lyon

Sponsor organisation

Hospices Civils De Lyon

Address

3 Quai Des Celestins, Bp 2251 Bp 2251

City

Lyon Cedex 02

Postcode

69229

Country

France

Scientific contact point

Organisation

Hospices Civils De Lyon

Contact name

Dr Jing XIE

Public contact point

Organisation

Hospices Civils De Lyon

Contact name

Dr Jing XIE

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

3 submissions — initial application plus substantial / non-substantial modifications