RecruitingNCT07187843

Study of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Brain-first and Body-first PD

Study of the Progression of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Patients With Parkinson's Disease Divided Into Brain-first and Body-first Phenotypes


Sponsor

Azienda USL Reggio Emilia - IRCCS

Enrollment

150 participants

Start Date

Sep 4, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This observational study aims to systematically characterize a cohort of patients with early-stage Parkinson's disease (PD) attending the Movement Disorders Center of AUSL-IRCCS Reggio Emilia, Italy. PD is the second most common neurodegenerative disorder, affecting about 1% of individuals over 60 years of age. The project will explore clinical and biological differences between the recently proposed "Brain-First" and "Body-First" phenotypes of PD. Patients will undergo detailed clinical evaluation, neuroimaging, and biomarker assessments (including neurodegeneration and neuroinflammation markers). Particular attention will be given to the progression of axial and cognitive symptoms, which represent major contributors to disability. Findings from this study are expected to improve early patient stratification, clarify disease mechanisms, and support the development of precision medicine strategies and future disease-modifying therapies.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating brain and body biomarkers (measurable biological signals) in people with Parkinson's disease to better understand why some people develop the disease starting in the brain ('brain-first') versus starting in the gut and nervous system of the body ('body-first'). Researchers will use sleep studies, specialized scans, and other assessments to explore these two subtypes. **You may be eligible if...** - You are 18 or older - You have been diagnosed with Parkinson's disease using established medical criteria - You are willing and able to provide informed consent **You may NOT be eligible if...** - Your Parkinson's diagnosis is uncertain or doubtful - You are under 18 - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERClinical assessments

standardized neurological examination, motor and non-motor symptom scales, cognitive testing, and autonomic symptom questionnaires.

OTHERPhenotypic classification

patients will be stratified into Brain-First and Body-First phenotypes based on the presence of RBD and instrumental findings.


Locations(1)

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, Italy

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NCT07187843


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