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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients diagnosed with PD according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease divided into brain-first and body-first phenotypes, based on the presence or absence of a REM sleep behavior disorder diagnosed using ambulatory polysomnography methods according to the criteria of the International Classification of Sleep Disorders (ICSD-3) criteria and on data from SPECT with DATSCAN and myocardial innervation scintigraphy \[123I-MIBG\]. - Free and willing to sign a consent form expressed by the participant. - At least 18 years of age. Who Should NOT Join This Trial: - Inability to express free and willing to sign a consent form. - Patient with a doubtful diagnosis. - Participant under 18 years of age. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Patients diagnosed with PD according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease divided into brain-first and body-first phenotypes, based on the presence or absence of a REM sleep behavior disorder diagnosed using ambulatory polysomnography methods according to the criteria of the International Classification of Sleep Disorders (ICSD-3) criteria and on data from SPECT with DATSCAN and myocardial innervation scintigraphy \[123I-MIBG\]. * Free and informed consent expressed by the participant. * At least 18 years of age. Exclusion Criteria: * Inability to express free and informed consent. * Patient with a doubtful diagnosis. * Participant under 18 years of age.

Treatments Being Tested

OTHER

Clinical assessments

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

OTHER

Phenotypic 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