Relationship Between Immunosuppressive Treatment Status and Clinical Course of Parkinson's Disease

NCT06834191 | Recruiting

• 1 other identifier: KB/164/2024
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.clinical Parkinson's disease motor assessments conducted by the research team -\> participants will be evaluated in the OFF state, meaning they will not have taken their Parkinson's disease medication the day of the assessment;
2. 2.completion of Parkinson's disease symptom scales;
3. 3.a one-time serum sample collection;
4. 4.detailed medical history obtainment from the participant by the research team, with a primary focus on the patient's immunosuppressive treatment history and individual clinical course of Parkinson's disease.

Conditions

Parkinson Disease

Keywords

Immunosuppression; Immunosuppressive treatment; cross-sectional study; observational study; Parkinson disease

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (6)

• Annual motor progression rate - Hoehn and Yahr scale

  Day 1

• Annual motor progression rate - Unified Parkinson's Disease Rating Scale PART II

  Day 1

• Serum inflammatory marker levels - IL-1β

  Day 1

• Serum inflammatory marker levels - IL-6

  Day 1

• Serum inflammatory marker levels - calprotectin

  Day 1

Study Arms (2)

People with Parkinson's receiving long - term immunosuppressive treatment - study group

People with Parkinson's without long-term immunosuppressive treatment history - control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Diagnosis of Parkinson's disease according to the International Parkinson and Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease;
• Provision of informed consent to participate in the study.
• Diagnosis of Parkinson's disease according to the International Parkinson and Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease;
• No history of regular use of immunosuppressive medications;
• Provision of informed consent to participate in the study.

You may not qualify if:

• Immunosuppressive drug administration at an ad hoc basis (i.e. when symptoms occur) or irregularly (i.e. drug taken at an inappropriate dose and/or with a regularity ineffective for the indicated disease);
• Use of immunosuppressive drugs for a period of less than 12 months;
• Ineffective treatment of the disease requiring the use of immunosuppressive drugs (no improvement/progression of disease symptoms);
• Advanced cancer; severe heart failure; severe renal failure; untreated autoimmune disease; active inflammation; diseases that impair drug absorption/metabolism;
• Dementia;
• Failure/inability to provide informed consent.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Neurology, Faculty of Health Science, Medical University of Warsaw

Warsaw, 02-091, Poland

RECRUITING

Related Publications (10)

• 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.

  PMID: 37458046 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.

  PMID: 26474316 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.

  PMID: 37309919 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.

  PMID: 30009205 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.

  PMID: 38686220 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.

  PMID: 29454662 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.

  PMID: 10673145 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.

  PMID: 27668667 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.

  PMID: 18582534 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.

  PMID: 35246670 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

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

Central Study Contacts

Julia M Nowak, MD

CONTACT

+48223265427; julia.nowak@wum.edu.pl

Monika Figura, MD, PhD

CONTACT

+48223265427; monika.figura@wum.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 19, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 23, 2025

Record last verified: 2025-01

Locations

PL (1)