Study of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Brain-first and Body-first PD
Recruiting · NCT07187843 · Observational (researchers observe without assigning treatment) · Lead sponsor: Azienda USL Reggio Emilia - IRCCS
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
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.
Where it is running
1 location listed.
- Azienda USL IRCCS di Reggio Emilia - Reggio Emilia, Italy