New Biomarkers in Parkinson's Disease

NCT05150158 | Unknown

• 1 other identifier: GATEKEEPER-857223
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 \[GBD 2016 Neurology Collaborators, 2019; Dorsey et al, 2018\]. 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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Number of patients with PD

  Patients with Parkinson's disease

  1 year

• Number of patients with early PD symptoms

  Patients presenting sub-clinical symptoms

  1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

Sponsors & Collaborators

• Neuromed IRCCS: lead
• NIM Competence Center for Digital Healthcare GmbH: collaborator

Study Sites (1)

Istituto Neurologico Mediterraneo NEUROMED I.R.C.C.S.

Pozzilli, Italy

Location

Related Publications (12)

• 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.

  PMID: 23359374 BACKGROUND

• Berg 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.

  PMID: 26474317 BACKGROUND

• Bloem 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.

  PMID: 33848468 BACKGROUND

• Dorsey 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.

  PMID: 30584159 BACKGROUND

• Du 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.

  PMID: 33833675 BACKGROUND

• GBD 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.

  PMID: 30879893 BACKGROUND

• Gilman 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.

  PMID: 18725592 BACKGROUND

• Heinzel 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.

  PMID: 31412427 BACKGROUND

• Hoglinger 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.

  PMID: 28467028 BACKGROUND

• McKeith 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.

  PMID: 28592453 BACKGROUND

• Schaeffer 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.

  PMID: 32247370 BACKGROUND

• Tolosa 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.

  PMID: 33894193 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Nicola D'Ascenzo

  Istituto Neurologico Mediterraneo NEUROMED I.R.C.C.S

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola D'Ascenzo

CONTACT

0865915321; nicola.dascenzo@neuromed.it

Nicola Modugno

CONTACT

nicola.modugno@neuromed.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Department Medical Physics and Engineering

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 8, 2021
• Study Start: December 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 8, 2021

Record last verified: 2021-11

Locations

IT (1)