Parkinson DiseaseNCT05150158
New Biomarkers in Parkinson's Disease
An observational study of Parkinson Disease, run by Neuromed IRCCS at 1 site in Italy.
Trial summary
Parkinson's disease (PD) is the second most common neurodegenerative disease and its prevalence is expected to double over the next 30 years, making it a leading cause of neurological disability [GBD 2016 Neurology Collaborators, 2019; Dorsey et al, 2018]. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2021to 31 Dec 2022
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants will be divided into 6 groups (each with at least 10 subjects) based on clinical characteristics: 1) patients with clinically defined PD; 2) patients with clinically probable PD; 3) patients with neurodegenerative parkinsonism, such as multiple system atrophy (MSA), progressive supranuclear palsy (PSP), Lewy body disease (DLB) or cortico-basal degeneration (CBD); 4) patients with secondary parkinsonism (vascular, iatrogenic, psychogenic, etc.); 5) patients with "probable" or "possible" prodromal PD; 6) healthy subjects with risk or prodromal factors for PD; 7) healthy subjects of equal age and sex without any risk or prodromal factor for PD.
Patients with clinically defined or probable PD will need to meet the criteria for the diagnosis of PD (clinically defined or probable) prepared by the Movement Disorder Society (MDS) in 2015 [Postuma et al, 2015]. Patients with neurodegenerative parkinsonism will have to meet the published diagnostic criteria for MSA [Gilman et al, 2008], PSP [Höglinger et al, 2017], DLB [McKeith et al, 2017] and CBD [Armstrong et al, 2013]. Patients with prodromal PD will have to meet the diagnostic criteria proposed by the MDS for the diagnosis of "probable" prodromal PD if the risk percentage of developing PD> 80%, or "possible" if the risk percentage of developing PD> 50 % [Berg et al, 2015; Heinzel et al, 2019]. The risk or prodromal factors proposed by the MDS to calculate the probability of prodromal PD include: male sex, exposure to pesticides, exposure to solvents, caffeine intake, smoking habit, familiarity (first degree relative with PD), hyperechogenicity of the substantia nigra on transcranial ultrasound, possible subthreshold parkinsonism (as assessed by UPDRS-III), REM sleep behavioral disorder (RBD), olfactory impairment, constipation, excessive daytime sleepiness, orthostatic hypotension, urinary dysfunction, severe erectile dysfunction, depression / anxiety, activity of the dopamine transporter, RBD confirmed by polysomnography, genetic tests, type II diabetes mellitus, physical activity, serum urate levels, cognitive functions assessed with the Mini Mental State Examination [Berg et al, 2015; Heinzel et al, 2019]. Healthy subjects with risk or prodromal factors for PD should have a probability of developing PD <50% according to the criteria of the MDS [Berg et al, 2015; Heinzel et al, 2019].
In addition to the selected patients, a study will also be conducted on patient data in the reference database of the proposing institution.
- Exclusion: Patients who do not consent to study participation
Trial locations and contacts
1 site in 1 country.
Nicola Modugno contact
Italy1 site
Istituto Neurologico Mediterraneo NEUROMED I.R.C.C.S.
Pozzilli
Nicola D'Ascenzo
About this study
Parkinson's disease (PD) is the second most common neurodegenerative disease and its prevalence is expected to double over the next 30 years, making it a leading cause of neurological disability [GBD 2016 Neurology Collaborators, 2019; Dorsey et al, 2018]. PD is characterized by motor symptoms, such as muscle stiffness, tremor, slowness of movement (bradykinesia) and postural instability, and non-motor symptoms, such as sphincter disorders, postural hypotension, cognitive disorders, depression, hyposmia, constipation and REM sleep behavioral disturbance. Unfortunately, the mechanisms leading to neuronal dysfunction and death in PD remain poorly known and there are currently no therapies capable of modifying their course [Bloem et al, 2021].
In this study we aim at defining a new set of biomarkers based on the combination between PET, blood metabolomics and natural language extracted from the keywords of electronic health records.
Read the detailed description
Much evidence suggests the existence of a preclinical stage of disease that begins many years before PD is diagnosed, when an individual appears normal (there are no symptoms or signs), but is already developing typical neuropathological changes. The prodromal phase follows, in which symptoms and signs are present, but are still insufficient to define the disease. In the clinical phase, cardinal motor symptoms become sufficiently evident to diagnose PD [Schaeffer et al, 2020; Toulouse et al, 2021]. For this reason, it is important to have reliable biomarkers that can help in early diagnosis, especially considering that disease-modifying therapies have a greater chance of success if they are started early, before a considerable number of dopaminergic neurons have undergone. death. Furthermore, there is also a need to better define PD subtypes that not only have different clinical presentation and prognosis, but also differ in the underlying pathogenetic mechanisms, requiring personalized therapeutic approaches [Tolosa et al, 2021]. Such biomarkers should be sensitive, specific, non-invasive, inexpensive, easily detectable and measurable [Du et al, 2021].
In recent years, numerous biomarkers of risk and / or prodromal phase have been identified and combined in search criteria for prodromal PD, with the aim of calculating the probability with which a patient is in the prodromal phase of PD. Apart from specific genetic risk markers, including above all GBA and LRRK2 mutations, REM sleep behavioral disturbance and PET / SPECT abnormalities are currently considered the most important prodromal biomarkers, capable of predicting PD with a high probability. [Berg et al, 2015; Heinzel et al, 2019]. However, new biomarkers are needed for a better understanding of the prodromal phase and its potential clinical-pathological subtypes and for a more precise calculation of the probability of MP [Bloem et al, 2021; Schaeffer et al, 2020].
Goals: The main objective of the present study is to identify new, more reliable biomarkers of PD and to develop a new, more accurate predictive model of disease.
The design is that of a longitudinal observational study. Participants will be divided into 6 groups (each with at least 20 subjects) based on clinical characteristics: 1) patients with clinically defined PD; 2) patients with clinically probable PD; 3) patients with neurodegenerative parkinsonism, such as multiple system atrophy (MSA), progressive supranuclear palsy (PSP), Lewy body disease (DLB) or cortico-basal degeneration (CBD); 4) patients with secondary parkinsonism (vascular, iatrogenic, psychogenic, etc.); 5) patients with "probable" or "possible" prodromal PD; 6) healthy subjects with risk or prodromal factors for PD; 7) healthy subjects of the same age and sex without any risk or prodromal factor for PD.
All participants will undergo a careful medical history, general and neurological physical examination, neuropsychological tests, structural brain imaging (MRI or CT) and PET with F-DOPA (or SPECT with DATSCAN), venous blood sampling for routine blood chemistry ( including blood count, erythrocyte sedimentation rate, urea and electrolytes, thyroid function, vitamin B12 and folic acid), metabolomic analysis, including lipidomics, genetic analysis, mononuclear cell separation, and the search for known biomarkers of PD. The severity and progression of the disease will be assessed through the use of specific scores, including the Unified Parkinson's Disease Rating Scale (UPDRS) and the Hoehn and Yahr scale.
Metabolomic analysis, including lipidomics, will be performed through liquid chromatography coupled with tandem mass spectrometry and genetic analysis using next generation sequencing (NGS). Structural imaging and PET with F-DOPA (or SPECT with DATSCAN) of each subject will be subjected to texture analysis, using dedicated software, in search of new, more reliable neuroradiological markers. In the texture analysis, 103 structural parameters will be extracted from the 89 regions of the Hammers brain, for a total of 8779 parameters. For each brain region the parameters will be reduced by Principal Component Analysis (PCA), selecting only the principal components that express 99.5% of the total variance. The ultimate goal will be to quantify, in each individual subject, the risk of developing PD using a convolutional neural network (CNN) with inputs consisting of the various clinical parameters evaluated and the main components selected from metabolomics and PET data.
All participants will be clinically re-examined on a three-monthly basis.
The analysis will be carried out together with the partner "NIM Competence Center for Digital Healthcare GmbH" (NIM), holder of the "GATEKEEPER 1st open call" research grant. The data, appropriately anonymized, will be included in the European Gatekeeper digital medicine platform by the NIM partner.
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with PD
Patients with Parkinson's disease
Measured: 1 year
Number of patients with early PD symptoms
Patients presenting sub-clinical symptoms
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Dec 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- NIM Competence Center for Digital Healthcare GmbH
- Responsible party
- Principal investigator, Nicola D'Ascenzo, Neuromed IRCCS
- Investigators
- Nicola D'Ascenzo, Principal investigator, Istituto Neurologico Mediterraneo NEUROMED I.R.C.C.S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150158
- Sponsor's protocol ID
- GATEKEEPER-857223
- Status last verified
- Nov 2021
- First submitted
- 26 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Armstrong MJ, Litvan I, Lang AE, Bak TH, Bhatia KP, Borroni B, Boxer AL, Dickson DW, Grossman M, Hallett M, Josephs KA, Kertesz A, Lee SE, Miller BL, Reich SG, Riley DE, Tolosa E, Troster AI, Vidailhet M, Weiner WJ. Criteria for the diagnosis of corticobasal degeneration. Neurology. 2013 Jan 29;80(5):496-503. doi: 10.1212/WNL.0b013e31827f0fd1.
PubMed 23359374Berg D, Postuma RB, Adler CH, Bloem BR, Chan P, Dubois B, Gasser T, Goetz CG, Halliday G, Joseph L, Lang AE, Liepelt-Scarfone I, Litvan I, Marek K, Obeso J, Oertel W, Olanow CW, Poewe W, Stern M, Deuschl G. MDS research criteria for prodromal Parkinson's disease. Mov Disord. 2015 Oct;30(12):1600-11. doi: 10.1002/mds.26431.
PubMed 26474317Bloem BR, Okun MS, Klein C. Parkinson's disease. Lancet. 2021 Jun 12;397(10291):2284-2303. doi: 10.1016/S0140-6736(21)00218-X. Epub 2021 Apr 10.
PubMed 33848468Dorsey ER, Sherer T, Okun MS, Bloem BR. The Emerging Evidence of the Parkinson Pandemic. J Parkinsons Dis. 2018;8(s1):S3-S8. doi: 10.3233/JPD-181474.
PubMed 30584159Du T, Wang L, Liu W, Zhu G, Chen Y, Zhang J. Biomarkers and the Role of alpha-Synuclein in Parkinson's Disease. Front Aging Neurosci. 2021 Mar 23;13:645996. doi: 10.3389/fnagi.2021.645996. eCollection 2021.
PubMed 33833675GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.
PubMed 30879893Gilman S, Wenning GK, Low PA, Brooks DJ, Mathias CJ, Trojanowski JQ, Wood NW, Colosimo C, Durr A, Fowler CJ, Kaufmann H, Klockgether T, Lees A, Poewe W, Quinn N, Revesz T, Robertson D, Sandroni P, Seppi K, Vidailhet M. Second consensus statement on the diagnosis of multiple system atrophy. Neurology. 2008 Aug 26;71(9):670-6. doi: 10.1212/01.wnl.0000324625.00404.15.
PubMed 18725592Heinzel S, Berg D, Gasser T, Chen H, Yao C, Postuma RB; MDS Task Force on the Definition of Parkinson's Disease. Update of the MDS research criteria for prodromal Parkinson's disease. Mov Disord. 2019 Oct;34(10):1464-1470. doi: 10.1002/mds.27802. Epub 2019 Aug 14.
PubMed 31412427Hoglinger GU, Respondek G, Stamelou M, Kurz C, Josephs KA, Lang AE, Mollenhauer B, Muller U, Nilsson C, Whitwell JL, Arzberger T, Englund E, Gelpi E, Giese A, Irwin DJ, Meissner WG, Pantelyat A, Rajput A, van Swieten JC, Troakes C, Antonini A, Bhatia KP, Bordelon Y, Compta Y, Corvol JC, Colosimo C, Dickson DW, Dodel R, Ferguson L, Grossman M, Kassubek J, Krismer F, Levin J, Lorenzl S, Morris HR, Nestor P, Oertel WH, Poewe W, Rabinovici G, Rowe JB, Schellenberg GD, Seppi K, van Eimeren T, Wenning GK, Boxer AL, Golbe LI, Litvan I; Movement Disorder Society-endorsed PSP Study Group. Clinical diagnosis of progressive supranuclear palsy: The movement disorder society criteria. Mov Disord. 2017 Jun;32(6):853-864. doi: 10.1002/mds.26987. Epub 2017 May 3.
PubMed 28467028McKeith IG, Boeve BF, Dickson DW, Halliday G, Taylor JP, Weintraub D, Aarsland D, Galvin J, Attems J, Ballard CG, Bayston A, Beach TG, Blanc F, Bohnen N, Bonanni L, Bras J, Brundin P, Burn D, Chen-Plotkin A, Duda JE, El-Agnaf O, Feldman H, Ferman TJ, Ffytche D, Fujishiro H, Galasko D, Goldman JG, Gomperts SN, Graff-Radford NR, Honig LS, Iranzo A, Kantarci K, Kaufer D, Kukull W, Lee VMY, Leverenz JB, Lewis S, Lippa C, Lunde A, Masellis M, Masliah E, McLean P, Mollenhauer B, Montine TJ, Moreno E, Mori E, Murray M, O'Brien JT, Orimo S, Postuma RB, Ramaswamy S, Ross OA, Salmon DP, Singleton A, Taylor A, Thomas A, Tiraboschi P, Toledo JB, Trojanowski JQ, Tsuang D, Walker Z, Yamada M, Kosaka K. Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium. Neurology. 2017 Jul 4;89(1):88-100. doi: 10.1212/WNL.0000000000004058. Epub 2017 Jun 7.
PubMed 28592453Schaeffer E, Postuma RB, Berg D. Prodromal PD: A new nosological entity. Prog Brain Res. 2020;252:331-356. doi: 10.1016/bs.pbr.2020.01.003. Epub 2020 Feb 10.
PubMed 32247370Tolosa E, Garrido A, Scholz SW, Poewe W. Challenges in the diagnosis of Parkinson's disease. Lancet Neurol. 2021 May;20(5):385-397. doi: 10.1016/S1474-4422(21)00030-2.
PubMed 33894193
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Biomarkers in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05150158
- Acronym / sponsor ID
- GATEKEEPER-857223
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Collaborators
- NIM Competence Center for Digital Healthcare GmbH
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 8 Dec 2021 (actual)
- 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 (PD) is the second most common neurodegenerative disease and its prevalence is expected to double over the next 30 years, making it a leading cause of neurological disability [GBD 2016 Neurology Collaborators, 2019; Dorsey et al, 2018]. PD is characterized by motor symptoms, such as muscle stiffness, tremor, slowness of movement (bradykinesia) and postural instability, and non-motor symptoms, such as sphincter disorders, postural hypotension, cognitive disorders, depression, hyposmia, constipation and REM sleep behavioral disturbance. Unfortunately, the mechanisms leading to neuronal dysfunction and death in PD remain poorly known and there are currently no therapies capable of modifying their course [Bloem et al, 2021].
In this study we aim at defining a new set of biomarkers based on the combination between PET, blood metabolomics and natural language extracted from the keywords of electronic health records.
Detailed description
Much evidence suggests the existence of a preclinical stage of disease that begins many years before PD is diagnosed, when an individual appears normal (there are no symptoms or signs), but is already developing typical neuropathological changes. The prodromal phase follows, in which symptoms and signs are present, but are still insufficient to define the disease. In the clinical phase, cardinal motor symptoms become sufficiently evident to diagnose PD [Schaeffer et al, 2020; Toulouse et al, 2021]. For this reason, it is important to have reliable biomarkers that can help in early diagnosis, especially considering that disease-modifying therapies have a greater chance of success if they are started early, before a considerable number of dopaminergic neurons have undergone. death. Furthermore, there is also a need to better define PD subtypes that not only have different clinical presentation and prognosis, but also differ in the underlying pathogenetic mechanisms, requiring personalized therapeutic approaches [Tolosa et al, 2021]. Such biomarkers should be sensitive, specific, non-invasive, inexpensive, easily detectable and measurable [Du et al, 2021].
In recent years, numerous biomarkers of risk and / or prodromal phase have been identified and combined in search criteria for prodromal PD, with the aim of calculating the probability with which a patient is in the prodromal phase of PD. Apart from specific genetic risk markers, including above all GBA and LRRK2 mutations, REM sleep behavioral disturbance and PET / SPECT abnormalities are currently considered the most important prodromal biomarkers, capable of predicting PD with a high probability. [Berg et al, 2015; Heinzel et al, 2019]. However, new biomarkers are needed for a better understanding of the prodromal phase and its potential clinical-pathological subtypes and for a more precise calculation of the probability of MP [Bloem et al, 2021; Schaeffer et al, 2020].
Goals: The main objective of the present study is to identify new, more reliable biomarkers of PD and to develop a new, more accurate predictive model of disease.
The design is that of a longitudinal observational study. Participants will be divided into 6 groups (each with at least 20 subjects) based on clinical characteristics: 1) patients with clinically defined PD; 2) patients with clinically probable PD; 3) patients with neurodegenerative parkinsonism, such as multiple system atrophy (MSA), progressive supranuclear palsy (PSP), Lewy body disease (DLB) or cortico-basal degeneration (CBD); 4) patients with secondary parkinsonism (vascular, iatrogenic, psychogenic, etc.); 5) patients with "probable" or "possible" prodromal PD; 6) healthy subjects with risk or prodromal factors for PD; 7) healthy subjects of the same age and sex without any risk or prodromal factor for PD.
All participants will undergo a careful medical history, general and neurological physical examination, neuropsychological tests, structural brain imaging (MRI or CT) and PET with F-DOPA (or SPECT with DATSCAN), venous blood sampling for routine blood chemistry ( including blood count, erythrocyte sedimentation rate, urea and electrolytes, thyroid function, vitamin B12 and folic acid), metabolomic analysis, including lipidomics, genetic analysis, mononuclear cell separation, and the search for known biomarkers of PD. The severity and progression of the disease will be assessed through the use of specific scores, including the Unified Parkinson's Disease Rating Scale (UPDRS) and the Hoehn and Yahr scale.
Metabolomic analysis, including lipidomics, will be performed through liquid chromatography coupled with tandem mass spectrometry and genetic analysis using next generation sequencing (NGS). Structural imaging and PET with F-DOPA (or SPECT with DATSCAN) of each subject will be subjected to texture analysis, using dedicated software, in search of new, more reliable neuroradiological markers. In the texture analysis, 103 structural parameters will be extracted from the 89 regions of the Hammers brain, for a total of 8779 parameters. For each brain region the parameters will be reduced by Principal Component Analysis (PCA), selecting only the principal components that express 99.5% of the total variance. The ultimate goal will be to quantify, in each individual subject, the risk of developing PD using a convolutional neural network (CNN) with inputs consisting of the various clinical parameters evaluated and the main components selected from metabolomics and PET data.
All participants will be clinically re-examined on a three-monthly basis.
The analysis will be carried out together with the partner "NIM Competence Center for Digital Healthcare GmbH" (NIM), holder of the "GATEKEEPER 1st open call" research grant. The data, appropriately anonymized, will be included in the European Gatekeeper digital medicine platform by the NIM partner.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be divided into 6 groups (each with at least 10 subjects) based on clinical characteristics: 1) patients with clinically defined PD; 2) patients with clinically probable PD; 3) patients with neurodegenerative parkinsonism, such as multiple system atrophy (MSA), progressive supranuclear palsy (PSP), Lewy body disease (DLB) or cortico-basal degeneration (CBD); 4) patients with secondary parkinsonism (vascular, iatrogenic, psychogenic, etc.); 5) patients with "probable" or "possible" prodromal PD; 6) healthy subjects with risk or prodromal factors for PD; 7) healthy subjects of equal age and sex without any risk or prodromal factor for PD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with PD
Time frame: 1 year
Patients with Parkinson's disease
Number of patients with early PD symptoms
Time frame: 1 year
Patients presenting sub-clinical symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Background: PubMed 23359374Armstrong MJ, Litvan I, Lang AE, Bak TH, Bhatia KP, Borroni B, Boxer AL, Dickson DW, Grossman M, Hallett M, Josephs KA, Kertesz A, Lee SE, Miller BL, Reich SG, Riley DE, Tolosa E, Troster AI, Vidailhet M, Weiner WJ. Criteria for the diagnosis of corticobasal degeneration. Neurology. 2013 Jan 29;80(5):496-503. doi: 10.1212/WNL.0b013e31827f0fd1.
- Background: PubMed 26474317Berg D, Postuma RB, Adler CH, Bloem BR, Chan P, Dubois B, Gasser T, Goetz CG, Halliday G, Joseph L, Lang AE, Liepelt-Scarfone I, Litvan I, Marek K, Obeso J, Oertel W, Olanow CW, Poewe W, Stern M, Deuschl G. MDS research criteria for prodromal Parkinson's disease. Mov Disord. 2015 Oct;30(12):1600-11. doi: 10.1002/mds.26431.
- Background: PubMed 33848468Bloem BR, Okun MS, Klein C. Parkinson's disease. Lancet. 2021 Jun 12;397(10291):2284-2303. doi: 10.1016/S0140-6736(21)00218-X. Epub 2021 Apr 10.
- Background: PubMed 30584159Dorsey ER, Sherer T, Okun MS, Bloem BR. The Emerging Evidence of the Parkinson Pandemic. J Parkinsons Dis. 2018;8(s1):S3-S8. doi: 10.3233/JPD-181474.
- Background: PubMed 33833675Du T, Wang L, Liu W, Zhu G, Chen Y, Zhang J. Biomarkers and the Role of alpha-Synuclein in Parkinson's Disease. Front Aging Neurosci. 2021 Mar 23;13:645996. doi: 10.3389/fnagi.2021.645996. eCollection 2021.
- Background: PubMed 30879893GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.
- Background: PubMed 18725592Gilman S, Wenning GK, Low PA, Brooks DJ, Mathias CJ, Trojanowski JQ, Wood NW, Colosimo C, Durr A, Fowler CJ, Kaufmann H, Klockgether T, Lees A, Poewe W, Quinn N, Revesz T, Robertson D, Sandroni P, Seppi K, Vidailhet M. Second consensus statement on the diagnosis of multiple system atrophy. Neurology. 2008 Aug 26;71(9):670-6. doi: 10.1212/01.wnl.0000324625.00404.15.
- Background: PubMed 31412427Heinzel S, Berg D, Gasser T, Chen H, Yao C, Postuma RB; MDS Task Force on the Definition of Parkinson's Disease. Update of the MDS research criteria for prodromal Parkinson's disease. Mov Disord. 2019 Oct;34(10):1464-1470. doi: 10.1002/mds.27802. Epub 2019 Aug 14.
- Background: PubMed 28467028Hoglinger GU, Respondek G, Stamelou M, Kurz C, Josephs KA, Lang AE, Mollenhauer B, Muller U, Nilsson C, Whitwell JL, Arzberger T, Englund E, Gelpi E, Giese A, Irwin DJ, Meissner WG, Pantelyat A, Rajput A, van Swieten JC, Troakes C, Antonini A, Bhatia KP, Bordelon Y, Compta Y, Corvol JC, Colosimo C, Dickson DW, Dodel R, Ferguson L, Grossman M, Kassubek J, Krismer F, Levin J, Lorenzl S, Morris HR, Nestor P, Oertel WH, Poewe W, Rabinovici G, Rowe JB, Schellenberg GD, Seppi K, van Eimeren T, Wenning GK, Boxer AL, Golbe LI, Litvan I; Movement Disorder Society-endorsed PSP Study Group. Clinical diagnosis of progressive supranuclear palsy: The movement disorder society criteria. Mov Disord. 2017 Jun;32(6):853-864. doi: 10.1002/mds.26987. Epub 2017 May 3.
- Background: PubMed 28592453McKeith IG, Boeve BF, Dickson DW, Halliday G, Taylor JP, Weintraub D, Aarsland D, Galvin J, Attems J, Ballard CG, Bayston A, Beach TG, Blanc F, Bohnen N, Bonanni L, Bras J, Brundin P, Burn D, Chen-Plotkin A, Duda JE, El-Agnaf O, Feldman H, Ferman TJ, Ffytche D, Fujishiro H, Galasko D, Goldman JG, Gomperts SN, Graff-Radford NR, Honig LS, Iranzo A, Kantarci K, Kaufer D, Kukull W, Lee VMY, Leverenz JB, Lewis S, Lippa C, Lunde A, Masellis M, Masliah E, McLean P, Mollenhauer B, Montine TJ, Moreno E, Mori E, Murray M, O'Brien JT, Orimo S, Postuma RB, Ramaswamy S, Ross OA, Salmon DP, Singleton A, Taylor A, Thomas A, Tiraboschi P, Toledo JB, Trojanowski JQ, Tsuang D, Walker Z, Yamada M, Kosaka K. Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium. Neurology. 2017 Jul 4;89(1):88-100. doi: 10.1212/WNL.0000000000004058. Epub 2017 Jun 7.
- Background: PubMed 32247370Schaeffer E, Postuma RB, Berg D. Prodromal PD: A new nosological entity. Prog Brain Res. 2020;252:331-356. doi: 10.1016/bs.pbr.2020.01.003. Epub 2020 Feb 10.
- Background: PubMed 33894193Tolosa E, Garrido A, Scholz SW, Poewe W. Challenges in the diagnosis of Parkinson's disease. Lancet Neurol. 2021 May;20(5):385-397. doi: 10.1016/S1474-4422(21)00030-2.
- Individual participant dataSharing planned: Undecided
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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.
Nicola Modugno contact
Nicola D'Ascenzo principal investigator
Istituto Neurologico Mediterraneo NEUROMED I.R.C.C.S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Neuromed IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2021. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola D'Ascenzo (0865915321, nicola.dascenzo@neuromed.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with PD (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT05150158, which also lists 12 linked publications.
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 8 Dec 2021.