Parkinson's DiseaseCompensationPDNCT02038608
Compensatory Mechanisms in Parkinson Disease (PD)
A study testing PET in people with Parkinson's Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- PET
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Jul 2015
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon, Hopital Neurologique Pierre Wertheimer
Bron, 69500
About this study
Official title: Pathophysiology of Non Motor Signs and Compensatory Mechanisms in Parkinson's Disease: Role of the Serotoninergic and Dopaminergic Lesions Studied by PET
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
- Being tested
- PET
- Keywords
- Parkinson, serotonin, dopamine, non motor, progression, PET
- Medical subject headings
- Parkinson Disease, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PETDevice
| Study group | Role | What they receive |
|---|---|---|
| PET | Experimental | Not described Receives: Device: PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
The neuropsychiatric manifestations studied are :
- hypo and hyperdopaminergic signs : ECMP scale
- Apathy using LARS scale
- Anxiety using BAI scale
- Depression using BDI scale (Beck Depression Inventory)
- Affective well-being and asthenia using visual analogic scales of Norris
- MATHYS scale
- Global cognitive scale : MATTIS
- Food behavior using TFEQ scale
- Personality : TCI-R scale
- Impulsivity by UPPS scale
Measured: 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
: 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.
Fatigue will be assessed using the PDFS-16 scale
Measured: 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
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.
Fatigue will be assessed using the PDQ39 (Parkinson's Disease Questionnaire) scale
Measured: These correlations will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startDec 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038608
- Sponsor's protocol ID
- 2012.722
- Acronym
- CompensationPD
- Status last verified
- Dec 2025
- First submitted
- 13 Jan 2014
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27538418
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiology of Non Motor Signs and Compensatory Mechanisms in Parkinson's Disease: Role of the Serotoninergic and Dopaminergic Lesions Studied by PET
- ClinicalTrials.gov ID
- NCT02038608
- Acronym / sponsor ID
- CompensationPD / 2012.722
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson, serotonin, dopamine, non motor, progression, PET
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET | Experimental | Device: PET |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET | Device | PET |
Primary outcome
Respective progression of both dopaminergic and serotoninergic lesions in Parkinson's disease
Time frame: This will be achieved at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).
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.
3 secondary outcomes
Correlations between neuropsychiatric observed in Parkinson's disease at different stages of evolution
Time frame: 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
Time frame: 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
Time frame: These correlations will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 27538418Maillet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET in people with Parkinson's Disease, run by Hospices Civils de Lyon at 1 site 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 13 inclusion and 14 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Respective progression of both dopaminergic and serotoninergic lesions in Parkinson's disease (time frame: This will be achieved at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).). 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 NCT02038608, which also lists 1 linked publication.
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 19 Dec 2025.