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The goal of this observational study is to learn if immunosuppressive drug treatment influences the clinical course of Parkinson's disease. Recent research suggests that Parkinson's disease may have an inflammatory background. Numerous studies have identified elevated levels of pro-inflammatory markers in people with Parkinson's disease. Therefore, immunosuppressive drugs may potentially affect the course of this disease.
The investigators will recruit people with Parkinson's disease, who receive long-term immunosuppressive treatment for other chronic illnesses, into the study group. The study will also recruit people with Parkinson's disease with no history of immunosuppressive drug treatment into the control group. The main question this study aims to answer is:
> Does immunosuppressive drug treatment slow down the onset and/or progression of Parkinson's disease?
Researchers will compare Parkinson's disease progression rates and serum inflammatory marker levels between the study and control group, to see if immunosuppressive drug treatment influences the course of Parkinson's disease.
The study requires each participant to attend one hospital appointment. This appointment will be approximately one hour long, and will involve:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People with Parkinson's receiving long - term immunosuppressive treatment - study group | |||
| People with Parkinson's without long-term immunosuppressive treatment history - control group |
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| Measure | Description | Time Frame |
|---|---|---|
| Annual motor progression rate - Unified Parkinson's Disease Rating Scale PART III OFF | This primary outcome will measure annual Parkinson's disease motor symptom progression rates using Part III (Motor Examination) of the Unified Parkinson's Disease Rating Scale (UPDRS). Assessments will be conducted in the OFF state, meaning the participant will not have taken any Parkinson's disease medication the day of the assessment. Part III of the UPDRS contains 18 items, the minimum value of UPDRS Part III is 0 points, and the maximum value is 132 points. In UPDRS Part III the higher the score, the worse the outcome. Annual progression rates will be calculated based on the time from the participant's motor symptom onset to the time of the appointment. | Day 1 |
| Annual LEDD increase rate | This secondary outcome will measure annual Parkinson's disease levodopa equivalent daily dose (LEDD) increase rates for each participant. Parkinson's disease medication taken by the participant will be procured at each participant's individual appointment. LEDD values will then be calculated based on the doses and types of Parkinson's disease medication taken by the participant. Annual LEDD rates will be calculated based on the LEDD value and time from the participant's motor symptom onset to the time of the appointment. | Day 1 |
| Age of motor symptom onset | This secondary outcome will measure the age of onset of Parkinson's disease motor symptoms. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Annual motor progression rate - Hoehn and Yahr scale | This primary outcome will measure annual Parkinson's disease motor symptom progression rates using the Hoehn and Yahr scale. This scale is used for staging functional disability associated with Parkinson's disease. The stages range from 1 to 5, and the higher the score the worse the outcome. Annual progression rates will be calculated based on the time from the participant's motor symptom onset to the time of the appointment. |
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Inclusion criteria for the study group:
Inclusion criteria for the control group:
Exclusion criteria for the study group:
Additional exclusion criteria for both the study and control groups:
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Participants will be recruited among patients of the Department of Neurology and Parkinsonism Clinic of the Faculty of Health Sciences, Medical University of Warsaw, Warsaw, Poland
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia M Nowak, MD | Contact | +48223265427 | julia.nowak@wum.edu.pl | |
| Monika Figura, MD, PhD | Contact | +48223265427 | monika.figura@wum.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Faculty of Health Science, Medical University of Warsaw | Recruiting | Warsaw | 02-091 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37458046 | Background | Brumm MC, Siderowf A, Simuni T, Burghardt E, Choi SH, Caspell-Garcia C, Chahine LM, Mollenhauer B, Foroud T, Galasko D, Merchant K, Arnedo V, Hutten SJ, O'Grady AN, Poston KL, Tanner CM, Weintraub D, Kieburtz K, Marek K, Coffey CS; Parkinson's Progression Markers Initiative. Parkinson's Progression Markers Initiative: A Milestone-Based Strategy to Monitor Parkinson's Disease Progression. J Parkinsons Dis. 2023;13(6):899-916. doi: 10.3233/JPD-223433. | |
| 26474316 |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Serum
| Day 1 |
| Annual motor progression rate - Unified Parkinson's Disease Rating Scale PART II | This primary outcome will measure annual Parkinson's disease motor symptom progression rates using Part II (Motor Aspects of Experiences of Daily Living ) of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Part II of the MDS-UPDRS contains 13 items, the minimum value of MDS-UPDRS Part II is 0 points, and the maximum value is 52 points. In UPDRS Part II the higher the score, the worse the outcome. Annual progression rates will be calculated based on the time from the participant's motor symptom onset to the time of the appointment. | Day 1 |
| Serum inflammatory marker levels - IL-1β | This secondary outcome measures the level of IL-1β in each participant at a single time-point. | Day 1 |
| Serum inflammatory marker levels - IL-6 | This secondary outcome measures the level of IL-6 in each participant at a single time-point. | Day 1 |
| Serum inflammatory marker levels - calprotectin | This secondary outcome measures the level of calprotectin in each participant at a single time-point. | Day 1 |
| Serum inflammatory marker levels - TNFα | This secondary outcome measures the level of TNFα in each participant at a single time-point. | Day 1 |
| Background |
| Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424. |
| 37309919 | Background | Dulski J, Heckman MG, Nowak JM, Wszolek ZK. Protective Effect of Glucocorticoids against Symptomatic Disease in CSF1R Variant Carriers. Mov Disord. 2023 Aug;38(8):1545-1549. doi: 10.1002/mds.29504. Epub 2023 Jun 13. |
| 30009205 | Background | Racette BA, Gross A, Vouri SM, Camacho-Soto A, Willis AW, Searles Nielsen S. Immunosuppressants and risk of Parkinson disease. Ann Clin Transl Neurol. 2018 May 31;5(7):870-875. doi: 10.1002/acn3.580. eCollection 2018 Jul. |
| 38686220 | Background | Bruggeman A, Vandendriessche C, Hamerlinck H, De Looze D, Tate DJ, Vuylsteke M, De Commer L, Devolder L, Raes J, Verhasselt B, Laukens D, Vandenbroucke RE, Santens P. Safety and efficacy of faecal microbiota transplantation in patients with mild to moderate Parkinson's disease (GUT-PARFECT): a double-blind, placebo-controlled, randomised, phase 2 trial. EClinicalMedicine. 2024 Mar 27;71:102563. doi: 10.1016/j.eclinm.2024.102563. eCollection 2024 May. |
| 29454662 | Background | Schwiertz A, Spiegel J, Dillmann U, Grundmann D, Burmann J, Fassbender K, Schafer KH, Unger MM. Fecal markers of intestinal inflammation and intestinal permeability are elevated in Parkinson's disease. Parkinsonism Relat Disord. 2018 May;50:104-107. doi: 10.1016/j.parkreldis.2018.02.022. Epub 2018 Feb 12. |
| 10673145 | Background | Franceschi C, Valensin S, Fagnoni F, Barbi C, Bonafe M. Biomarkers of immunosenescence within an evolutionary perspective: the challenge of heterogeneity and the role of antigenic load. Exp Gerontol. 1999 Dec;34(8):911-21. doi: 10.1016/s0531-5565(99)00068-6. |
| 27668667 | Background | Qin XY, Zhang SP, Cao C, Loh YP, Cheng Y. Aberrations in Peripheral Inflammatory Cytokine Levels in Parkinson Disease: A Systematic Review and Meta-analysis. JAMA Neurol. 2016 Nov 1;73(11):1316-1324. doi: 10.1001/jamaneurol.2016.2742. |
| 18582534 | Background | Brodacki B, Staszewski J, Toczylowska B, Kozlowska E, Drela N, Chalimoniuk M, Stepien A. Serum interleukin (IL-2, IL-10, IL-6, IL-4), TNFalpha, and INFgamma concentrations are elevated in patients with atypical and idiopathic parkinsonism. Neurosci Lett. 2008 Aug 22;441(2):158-62. doi: 10.1016/j.neulet.2008.06.040. Epub 2008 Jun 19. |
| 35246670 | Background | Tansey MG, Wallings RL, Houser MC, Herrick MK, Keating CE, Joers V. Inflammation and immune dysfunction in Parkinson disease. Nat Rev Immunol. 2022 Nov;22(11):657-673. doi: 10.1038/s41577-022-00684-6. Epub 2022 Mar 4. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |