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Enrolling by Invitation

NCT Number: NCT07163156

Prolactin, Inflammation, and Parkinson's Severity

This cross-sectional observational study aims to evaluate the relationship between serum prolactin levels, peripheral inflammatory markers (NLR, PLR, SII, CRP), and disease severity in patients with Parkinson's disease (PD). A total of at least 300 patients diagnosed with idiopathic PD will be included. Disease severity will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS) and the Modified Hoehn-Yahr staging system. Serum and salivary prolactin levels will be measured using ELISA, while inflammatory markers will be calculated from routine blood tests. The study seeks to clarify whether prolactin and systemic inflammation indicators may serve as non-invasive biomarkers for disease progression and prognosis in PD, with particular emphasis on postmenopausal women.

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Diagnosis of idiopathic Parkinson's disease confirmed by a neurologist
  • Both male and postmenopausal female patients
  • Patients able to provide informed consent
  • Clinically stable enough to undergo blood and saliva sampling, as well as neurological assessment

Exclusion criteria

  • Premenopausal female patients
  • Patients with secondary or atypical parkinsonism (e.g., drug-induced, vascular, atypical parkinsonian syndromes)
  • Known endocrine disorders affecting prolactin levels (e.g., prolactinoma, pituitary adenoma, hypothyroidism)
  • Use of medications known to alter prolactin secretion (e.g., antipsychotics, dopamine antagonists, estrogen therapy)
  • History of other neurodegenerative diseases (e.g., Alzheimer's, Huntington's)
  • Presence of active infection, chronic inflammatory disease, or malignancy
  • Severe renal, hepatic, or cardiac failure
  • Inability to provide informed consent

Treatment and study plan

Primary outcomes

  1. Systemic inflammatory markers

    Time frame: 1 year later

    NLR, PLR, SII, CRP

  2. Prolactin Level

    Time frame: 1 year later

    Serum prolactine levels

Sponsors and collaborators

Lead sponsor

Çanakkale Onsekiz Mart University

Other

Registry information

Official study title

The Relationship of Prolactin and Inflammatory Markers With Parkinson's Disease Severity: Clinical and Biochemical Evaluation

Acronym: PRIPS

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 9, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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