NCT07163156

Enrolling By Invitation

Prolactin, Inflammation, and Parkinson's Severity

Çanakkale Onsekiz Mart University Source

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Other study identifiers

Sponsor study identifier

COMU-FNN-1

Secondary identifiers

NOT YET

OTHER_GRANT · Canakkale Onsekiz Mart University

Study Type

observational

Estimated enrollment

300

Locations

1 country

Sites

1

Timeline

Study Start

August 14, 2025

Actual (reported)

Primary Completion

December 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: enrolling by invitation
Estimated enrollment: 300 participants
Study completion date: June 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 14, 2025
Actual (reported)
First Submitted
August 23, 2025
Actual (reported)
First Posted
September 9, 2025
Actual (reported)
Primary Completion
December 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: September 9, 2025
Status Verified: August 2025
Last Update Submitted: September 1, 2025

Conditions

Idiopathic Parkinson Disease Inflammation Prolactin Prolactin Levels

Outcome Measures

Primary Outcomes (2)

Systemic inflammatory markers
NLR, PLR, SII, CRP
1 year later
Prolactin Level
Serum prolactine levels
1 year later

Study Arms (1)

1

Parkinson's Disease Patients

Eligibility Criteria

Age18 Years+

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

The study population will consist of at least 300 adult patients (≥18 years) diagnosed with idiopathic Parkinson's disease who are followed at the Neurology Department of Çanakkale Onsekiz Mart University. Both male and postmenopausal female patients will be included. Participants must be clinically stable and able to undergo neurological evaluation, serum and salivary prolactin testing, and routine laboratory investigations. Patients with atypical or secondary parkinsonism, endocrine disorders affecting prolactin levels, active infection, chronic inflammatory disease, or malignancy will be excluded.

You may qualify if:

Sponsors & Collaborators

Çanakkale Onsekiz Mart University
Otherlead

Study Sites (1)

Çanakkale Onsekiz Mart University

Çanakkale, Merkez, 17020, Turkey (Türkiye)

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Parkinson DiseaseInflammation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assoc. Prof.

Study Record Dates

First Submitted

August 23, 2025

First Posted

September 9, 2025

Study Start

August 14, 2025

Actual (reported)

Primary Completion

December 2025

Estimated (date passed)

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Recruiting

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

September 9, 2025

Record last verified: 2025-08

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT07163156
Data provider: ClinicalTrials.gov
Source updated: 2025-09-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:57 UTC

Locations

TR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

1

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations