Compensatory Mechanisms in Parkinson Disease (PD)

NCT02038608 | Completed

• 1 other identifier: 2012.722
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease is characterized by a large number of non motor, especially neuropsychiatric, signs. Their pathophysiology is complex but the role of dopaminergic and serotoninergic systems dysfunction is suggested by several studies. In addition, the serotoninergic system is involved in the pathophysiology of dyskinesias. Very few studies have analyzed the abnormalities of these two neurotransmission systems at disease onset, in de novo PD patients. Furthermore, the parallel evolution of the degeneration of the dopaminergic and serotoninergic systems with disease progression remains unknown. Thus the present study aims at determining, by using PET and 11C-PE2I and 11C-DASB the respective role of the serotoninergic and dopaminergic systems dysfunction in motor and non motor manifestations in PD, at different evolution stages.

Conditions

Parkinson's Disease

Keywords

Parkinson; serotonin; dopamine; non motor; progression; PET

Outcome Measures

Primary Outcomes (1)

• Respective progression of both dopaminergic and serotoninergic lesions in Parkinson's disease

  Dopaminergic lesions will be determined by positron emission tomography (PET) using 11C-PE2I in 3 groups of PD patients (de novo; mid-stage (4-7 years of evolution); late-stage (8-10 years of evolution). Serotoninergic lesions will be assessed by positron emission tomography (PET) using 11C-DASB in the same 3 groups of PD patients. In addition a control group will be included.

  This will be achieved at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).

Secondary Outcomes (3)

• Correlations between neuropsychiatric observed in Parkinson's disease at different stages of evolution

  These correlations will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).

• Role of dopaminergic and serotoninergic lesions in fatigue

  This will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).

• Relationship between the severity of dopaminergic and serotoninergic lesions and the quality of life

  These correlations will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).

Study Arms (1)

PET

EXPERIMENTAL

Device: PET

Interventions

PET DEVICE

PET

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients
• Patients presenting doparesponsive Parkinson's disease
• Patient's age between 40 and 70 years old
• Absence of other neurological or psychiatric disease
• Absence of cognitive decline ( MATTIS \> 130)
• For women of childbearing age a pregnancy test and a contraceptive method will be required
• Informed consent sign
• Healthy subjects
• subject's age between 40 and 70 years old
• Absence of neurological or psychiatric disease
• Absence of cognitive decline ( MATTIS \> 130)
• For women of childbearing age a pregnancy test and a contraceptive method will be required
• Informed consent sign

You may not qualify if:

• Patients
• patient's age \< 40 years old or \> 70 years old
• Other neurological or psychiatric disease
• Cognitive decline (MATTIS \< 130).
• Having participated to a PET or SPECT study in the last 12 months
• Pregnancy
• Severe concomitant disease
• Healthy subjects
• subject's age \< 40 years old or \> 70 years old
• Neurological or psychiatric disease
• Cognitive decline (MATTIS \< 130).
• Having participated to a PET or SPECT study in the last 12 months
• Pregnancy
• Severe concomitant disease

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon, Hopital Neurologique Pierre Wertheimer

Bron, 69500, France

Location

Related Publications (1)

• Maillet A, Krack P, Lhommee E, Metereau E, Klinger H, Favre E, Le Bars D, Schmitt E, Bichon A, Pelissier P, Fraix V, Castrioto A, Sgambato-Faure V, Broussolle E, Tremblay L, Thobois S. The prominent role of serotonergic degeneration in apathy, anxiety and depression in de novo Parkinson's disease. Brain. 2016 Sep;139(Pt 9):2486-502. doi: 10.1093/brain/aww162. Epub 2016 Aug 17.

  PMID: 27538418 RESULT

MeSH Terms

Conditions

Parkinson Disease; Disease Progression

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 16, 2014
• Study Start: December 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)