Parkinson DiseaseDATACOMTNCT02869945
Compensation Mechanisms in Parkinson's Disease
A study testing Identification of COMT HH, COMT HL or COMT LL genes, Brain MRI with resting state scan and Brain MPET in people with Parkinson Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Parkinson's disease onset is clinically defined as the appearance of motor symptoms including akinesia, tremor and hypertonia. Several studies have shown that motor symptoms occur when at least 50 % of dopaminergic neurons are lost. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Identification of COMT HH, COMT HL or COMT LL genes, Brain MRI with resting state scan and Brain MPET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to 1 Jul 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman ≥ 18 years old,
- Caucasian origin
- Parkinson's disease considered to be probable as defined by the criteria of UK Parkinson's disease Brain Bank (Hugues and coll 2002)
- Absence of anti-parkinsonian medication
- Patient affilied to a social security system
- Signed information consent form
Who cannot join
- Parkinsonian syndrome secondary to neuroleptics
- Atypical parkinsonian syndrome such a multisystem atrophy, progressive supranuclear paralysis, dementia with levy bodies.
- MRI contraindication (claustrophobia, not compatible mechanical heart valve MRI, pacemaker, cochlear implant, other body ferromagnetic objects, pregnancy) - MPET contraindication (pregnancy, feeding, hypersensitivity to ioflupane [123]
- Patient under guardianship or trusteeship
- Any other significant pathology that could prevent patient participation and achievement of planned examinations (except for lumbar puncture)
- Patient participating or having participated in other biomedical research involving a drug in the three months prior to inclusion
- Specific exclusion criteria if lumbar puncture is accepted by the patient: Anticoagulation or antiplatelet treatment; history of hemostasis disorders; platelets <150,000 mm3; TP <80%; TCA (patient / control)> 1.2.
- Hypersensitivity to local anesthetics with amide link or to any of the excipients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dopaminergic Denervation and COMT Polymorphism in de Novo Patients With Parkinson's Disease
Parkinson's disease onset is clinically defined as the appearance of motor symptoms including akinesia, tremor and hypertonia. Several studies have shown that motor symptoms occur when at least 50 % of dopaminergic neurons are lost. However, there are evidence suggesting that the level of dopaminergic denervation is not homogenous at the time of diagnosis.
Some patients have a higher level of dopaminergic loss at disease onset indicating the existence of compensation mechanisms. The aim of this study is to decipher how the metabolism of dopamine is involved in this compensation with a focus on the polymorphism of the COMT gene. This gene is expressed according to two variant: (i) COMT H that encodes a form of the enzyme with a high level of activity and (ii) COMT L that encode a form of the enzyme with a low level of activity. Thus, there are 3 possible genotypes in the population: (i) COMT HH associated with an increased degradation of dopamine, (ii) COMT LL associated with a decreased degradation of dopamine and (iii) COMT HH (intermediary between COMT HH and COMT LL).
Read more
The hypothesis is that this polymorphism of the COMT gene may participate to compensation mechanisms in early PD. Patients with COMT HH genotype may have an earlier motor symptoms onset than patients with COMT LL genotype.
To test this hypothesis, we will recruit 51 patients with de novo PD will be recruited (17 patients for each genotype). Given the distribution of COMT polymorphism in the population, a maximum sample of 76 patients will be screened to recruit 17 patients for each genotype.
Clinical evaluation will include MDS-UPDRS, Non Motor Symptoms Scale, segmental symptoms scale, Montreal Cognitive assessment, MMSE, Frontal assessment battery and Parkinson's disease behavioral assessment scale (ECMP). All the patients will have a monophotonic emission tomography with I-123-Ioflupane in order to assess the level of dopaminergic denervation and an MRI scan with resting state study. Cerebrospinal fluid sampling will be optional and will allow direct measurements of dopamine metabolites.
The main outcome measure will be the level of dopaminergic denervation on I-123-Ioflupane scans according to COMT genotype, age, gender and severity of motor symptoms on the MDS-UPDRS part 3.
If this hypothesis is confirmed, this will allow to test the efficacy of COMT inhibitors in order to delay dopaminergic drugs initiation for PD patients.
Read the detailed description
Parkinson's disease onset is clinically defined as the appearance of motor symptoms including akinesia, tremor and hypertonia. Several studies have shown that motor symptoms occur when at least 50 % of dopaminergic neurons are lost. However, there are evidence suggesting that the level of dopaminergic denervation is not homogenous at the time of diagnosis. Some patients have a higher level of dopaminergic loss at disease onset indicating the existence of compensation mechanisms.
The aim of this study is to decipher how the metabolism of dopamine is involved in this compensation with a focus on the polymorphism of the COMT gene. This gene is expressed according to two variants: (i) COMT H that encodes a form of the enzyme with a high level of aactivity and (ii) COMT L that encode a form of the enzyme with a low level of activity. Thus, there are 3 possible genotypes in the population: (i) COMT HH associated with an increased degradation of dopamine, (ii) COMT LL associated with a decreased degradation of dopamine and (iii) COMT HH (intermediary between COMT HH and COMT LL).
The hypothesis is that this polymorphism of the COMT gene may participate to compensation mechanisms in early PD. Patients with COMT HH genotype may have an earlier motor symptoms onset than patients with COMT LL genotype.
To test this hypothesis, 51 patients with de novo PD will be included (17 patients for each genotype). Given the distribution of COMT polymorphism in the population, a maximum sample of 76 patients will be screened for inclusion of 17 patients for each genotype.
Only untreated patients will be included in the study in order to have a reliable assessment of motor severity without interference of dopaminergic drugs.
The study will be scheduled as follow:
- At the first visit (V1), inclusion criteria will be checked and patients will sign the informed consent. COMT genotype of selected patients will be analyzed.
- Result of COMT genotype will be obtained within 4 weeks. Only the 17 first patients with each genotype will continue the study
- For these patients, an evaluation visit with clinical assessment including MDS-UPDRS, Non Motor Symptoms Scale, segmental symptoms scale, Montreal Cognitive assessment, MMSE, Frontal assessment battery and Parkinson's disease behavioral assessment scale (ECMP) will be performed..
All the patients will have a monophotonic emission tomography with I-123-Ioflupane in order to assess the level of dopaminergic denervation. An MRI scan with resting state study will also be performed to assess the compensation mechanisms at the networks level. Cerebrospinal fluid sampling will be optional and will allow direct measurements of dopamine metabolites.
The main outcome measure will be the level of dopaminergic denervation on I-123-Ioflupane scans according to COMT genotype with and without adjustment for age, gender and severity of motor symptoms on the MDS-UPDRS part 3.
Secondary outcome measures will include:
- level of dopaminergic denervation compared across the 3 genotypes (COMT HH, COMT HL and COMT HH) with and without adjustment for age, gender and motor scores
- determination of functional compensation at the networks scale assessed on fMRI resting state scan according to dopaminergic denervation
- determination of CSF dopamine metabolite profile at the time of diagnosis (CSF sampling will be optional).
If this hypothesis is confirmed, this will allow to test the efficacy of COMT inhibitors in order to delay dopaminergic drugs initiation for PD patients.
- Conditions
- Parkinson Disease
- Being tested
- Identification of COMT HH, COMT HL or COMT LL genes, Brain MRI with resting state scan, Brain MPET
- Keywords
- de novo untreated Parkinson Disease, genetic, COMT Polymorphism, gene, brain MRI, brain MPET
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification of COMT HH, COMT HL or COMT LL genesGenetic
COMT HH, COMT HL or COMT LL genes identification
Brain MRI with resting state scanOther
MRI scan with resting state study to be performed to assess the compensation mechanisms at the networks level.
Brain MPETOther
Monophotonic emission tomography with I-123-Ioflupane to assess the level of dopaminergic denervation.
| Study group | Role | What they receive |
|---|---|---|
| COMT HH | Other | COMT HH gene Receives: Genetic: Identification of COMT HH, COMT HL or COMT LL genes; Other: Brain MRI with resting state scan; Other: Brain MPET |
| COMT HL | Other | COMT HL gene Receives: Genetic: Identification of COMT HH, COMT HL or COMT LL genes; Other: Brain MRI with resting state scan; Other: Brain MPET |
| COMT LL | Other | COMT LL gene Receives: Genetic: Identification of COMT HH, COMT HL or COMT LL genes; Other: Brain MRI with resting state scan; Other: Brain MPET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the degree of presynaptic dopaminergic denervation across the 3 genotypes group (COMT HH, COMT HL and COMT LL) at the time of diagnostic of Parkinson disease
The degree of presynaptic dopaminergic denervation estimated by the potential links of 123I-FP-CIT (radioligand dopamine transporter) on scintigraphy images of single photon emission
Measured: Within 3 months after inclusion
Secondary outcomes (4)
Degree of presynaptic denervation in three groups: COMT HH, COMT LL, COMT HL with and without adjustment for age, sex and UPDRS III score
Measured: Within 3 months after inclusion
CSF dopamine metabolite levels at the time of diagnosis (CSF sampling will be optional) in the groups COMT HH, COMT HL and COMT LL
Measured: Within 3 months after inclusion
Functional connectivity resting MRI Index obtained by full integration and graph theory based on genotypes (COMT HH, COMT LL, COMT HL) and denervation degree (MPET).
Measured: Within 3 months after inclusion
MDS UPDRS-III motor score according to the genotypes (COMT HH, COMT LL, COMT HL) and denervation degree observed by MPET
Measured: Within 3 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startSep 2016
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Grabli, MD-PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869945
- Sponsor's protocol ID
- P130939
- Acronym
- DATACOMT
- Status last verified
- Feb 2022
- First submitted
- 4 Aug 2016
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopaminergic Denervation and COMT Polymorphism in de Novo Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02869945
- Acronym / sponsor ID
- DATACOMT / P130939
- Conditions
- Parkinson Disease
- Keywords
- de novo untreated Parkinson Disease, genetic, COMT Polymorphism, gene, brain MRI, brain MPET
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 17 Aug 2016 (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 onset is clinically defined as the appearance of motor symptoms including akinesia, tremor and hypertonia. Several studies have shown that motor symptoms occur when at least 50 % of dopaminergic neurons are lost. However, there are evidence suggesting that the level of dopaminergic denervation is not homogenous at the time of diagnosis.
Some patients have a higher level of dopaminergic loss at disease onset indicating the existence of compensation mechanisms. The aim of this study is to decipher how the metabolism of dopamine is involved in this compensation with a focus on the polymorphism of the COMT gene. This gene is expressed according to two variant: (i) COMT H that encodes a form of the enzyme with a high level of activity and (ii) COMT L that encode a form of the enzyme with a low level of activity. Thus, there are 3 possible genotypes in the population: (i) COMT HH associated with an increased degradation of dopamine, (ii) COMT LL associated with a decreased degradation of dopamine and (iii) COMT HH (intermediary between COMT HH and COMT LL).
The hypothesis is that this polymorphism of the COMT gene may participate to compensation mechanisms in early PD. Patients with COMT HH genotype may have an earlier motor symptoms onset than patients with COMT LL genotype.
To test this hypothesis, we will recruit 51 patients with de novo PD will be recruited (17 patients for each genotype). Given the distribution of COMT polymorphism in the population, a maximum sample of 76 patients will be screened to recruit 17 patients for each genotype.
Clinical evaluation will include MDS-UPDRS, Non Motor Symptoms Scale, segmental symptoms scale, Montreal Cognitive assessment, MMSE, Frontal assessment battery and Parkinson's disease behavioral assessment scale (ECMP). All the patients will have a monophotonic emission tomography with I-123-Ioflupane in order to assess the level of dopaminergic denervation and an MRI scan with resting state study. Cerebrospinal fluid sampling will be optional and will allow direct measurements of dopamine metabolites.
The main outcome measure will be the level of dopaminergic denervation on I-123-Ioflupane scans according to COMT genotype, age, gender and severity of motor symptoms on the MDS-UPDRS part 3.
If this hypothesis is confirmed, this will allow to test the efficacy of COMT inhibitors in order to delay dopaminergic drugs initiation for PD patients.
Detailed description
Parkinson's disease onset is clinically defined as the appearance of motor symptoms including akinesia, tremor and hypertonia. Several studies have shown that motor symptoms occur when at least 50 % of dopaminergic neurons are lost. However, there are evidence suggesting that the level of dopaminergic denervation is not homogenous at the time of diagnosis. Some patients have a higher level of dopaminergic loss at disease onset indicating the existence of compensation mechanisms.
The aim of this study is to decipher how the metabolism of dopamine is involved in this compensation with a focus on the polymorphism of the COMT gene. This gene is expressed according to two variants: (i) COMT H that encodes a form of the enzyme with a high level of aactivity and (ii) COMT L that encode a form of the enzyme with a low level of activity. Thus, there are 3 possible genotypes in the population: (i) COMT HH associated with an increased degradation of dopamine, (ii) COMT LL associated with a decreased degradation of dopamine and (iii) COMT HH (intermediary between COMT HH and COMT LL).
The hypothesis is that this polymorphism of the COMT gene may participate to compensation mechanisms in early PD. Patients with COMT HH genotype may have an earlier motor symptoms onset than patients with COMT LL genotype.
To test this hypothesis, 51 patients with de novo PD will be included (17 patients for each genotype). Given the distribution of COMT polymorphism in the population, a maximum sample of 76 patients will be screened for inclusion of 17 patients for each genotype.
Only untreated patients will be included in the study in order to have a reliable assessment of motor severity without interference of dopaminergic drugs.
The study will be scheduled as follow:
- At the first visit (V1), inclusion criteria will be checked and patients will sign the informed consent. COMT genotype of selected patients will be analyzed.
- Result of COMT genotype will be obtained within 4 weeks. Only the 17 first patients with each genotype will continue the study
- For these patients, an evaluation visit with clinical assessment including MDS-UPDRS, Non Motor Symptoms Scale, segmental symptoms scale, Montreal Cognitive assessment, MMSE, Frontal assessment battery and Parkinson's disease behavioral assessment scale (ECMP) will be performed..
All the patients will have a monophotonic emission tomography with I-123-Ioflupane in order to assess the level of dopaminergic denervation. An MRI scan with resting state study will also be performed to assess the compensation mechanisms at the networks level. Cerebrospinal fluid sampling will be optional and will allow direct measurements of dopamine metabolites.
The main outcome measure will be the level of dopaminergic denervation on I-123-Ioflupane scans according to COMT genotype with and without adjustment for age, gender and severity of motor symptoms on the MDS-UPDRS part 3.
Secondary outcome measures will include:
- level of dopaminergic denervation compared across the 3 genotypes (COMT HH, COMT HL and COMT HH) with and without adjustment for age, gender and motor scores
- determination of functional compensation at the networks scale assessed on fMRI resting state scan according to dopaminergic denervation
- determination of CSF dopamine metabolite profile at the time of diagnosis (CSF sampling will be optional).
If this hypothesis is confirmed, this will allow to test the efficacy of COMT inhibitors in order to delay dopaminergic drugs initiation for PD patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COMT HH | Other | Genetic: Identification of COMT HH, COMT HL or COMT LL genes, Other: Brain MRI with resting state scan, Other: Brain MPETCOMT HH gene |
| COMT HL | Other | Genetic: Identification of COMT HH, COMT HL or COMT LL genes, Other: Brain MRI with resting state scan, Other: Brain MPETCOMT HL gene |
| COMT LL | Other | Genetic: Identification of COMT HH, COMT HL or COMT LL genes, Other: Brain MRI with resting state scan, Other: Brain MPETCOMT LL gene |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Man or woman ≥ 18 years old,
- Caucasian origin
- Parkinson's disease considered to be probable as defined by the criteria of UK Parkinson's disease Brain Bank (Hugues and coll 2002)
- Absence of anti-parkinsonian medication
- Patient affilied to a social security system
Key exclusion criteria (8 listed)
- Parkinsonian syndrome secondary to neuroleptics
- Atypical parkinsonian syndrome such a multisystem atrophy, progressive supranuclear paralysis, dementia with levy bodies.
- MRI contraindication (claustrophobia, not compatible mechanical heart valve MRI, pacemaker, cochlear implant, other body ferromagnetic objects, pregnancy) - MPET contraindication (pregnancy, feeding, hypersensitivity to ioflupane [123]
- Patient under guardianship or trusteeship
- Any other significant pathology that could prevent patient participation and achievement of planned examinations (except for lumbar puncture)
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 |
|---|---|---|
| Identification of COMT HH, COMT HL or COMT LL genesCOMT HH, COMT HL or COMT LL genes identification | Genetic | COMT HH, COMT HL, COMT LL |
| Brain MRI with resting state scanMRI scan with resting state study to be performed to assess the compensation mechanisms at the networks level. | Other | COMT HH, COMT HL, COMT LL |
| Brain MPETMonophotonic emission tomography with I-123-Ioflupane to assess the level of dopaminergic denervation. | Other | COMT HH, COMT HL, COMT LL |
Primary outcome
Comparison of the degree of presynaptic dopaminergic denervation across the 3 genotypes group (COMT HH, COMT HL and COMT LL) at the time of diagnostic of Parkinson disease
Time frame: Within 3 months after inclusion
The degree of presynaptic dopaminergic denervation estimated by the potential links of 123I-FP-CIT (radioligand dopamine transporter) on scintigraphy images of single photon emission
4 secondary outcomes
Degree of presynaptic denervation in three groups: COMT HH, COMT LL, COMT HL with and without adjustment for age, sex and UPDRS III score
Time frame: Within 3 months after inclusion
CSF dopamine metabolite levels at the time of diagnosis (CSF sampling will be optional) in the groups COMT HH, COMT HL and COMT LL
Time frame: Within 3 months after inclusion
Functional connectivity resting MRI Index obtained by full integration and graph theory based on genotypes (COMT HH, COMT LL, COMT HL) and denervation degree (MPET).
Time frame: Within 3 months after inclusion
MDS UPDRS-III motor score according to the genotypes (COMT HH, COMT LL, COMT HL) and denervation degree observed by MPET
Time frame: Within 3 months after inclusion
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 18 Feb 2022.
- Individual participant dataSharing planned: No
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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.
David Grabli, MD-PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Identification of COMT HH, COMT HL or COMT LL genes, Brain MRI with resting state scan and Brain MPET in people with Parkinson Disease, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 8 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 18 Feb 2022. 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?
Comparison of the degree of presynaptic dopaminergic denervation across the 3 genotypes group (COMT HH, COMT HL and COMT LL) at the time of diagnostic of Parkinson disease (time frame: Within 3 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2022.