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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Azienda USL IRCCS di Reggio Emilia
RECRUITING
Reggio Emilia
Contact Information
Primary
Francesco Cavallieri, MD
francesco.cavallieri@ausl.re.it
Backup
Stefania Croci, BSc
stefania.Croci@ausl.re.it
Time Frame
Start Date: 2024-09-04
Estimated Completion Date: 2031-05
Participants
Target number of participants: 150
Treatments
Early Parkinson's Disease (Brain-First phenotype)
Patients with early-stage Parkinson's disease without REM sleep behavior disorder (RBD), consistent with a Brain-First phenotype. These patients typically show early central dopaminergic deficits followed by peripheral involvement.
Early Parkinson's Disease (Body-First phenotype)
Patients with early-stage Parkinson's disease with REM sleep behavior disorder (RBD) before or at motor onset, consistent with a Body-First phenotype. These patients are expected to show early peripheral involvement (e.g., cardiac MIBG denervation) preceding central dopaminergic loss.
Related Therapeutic Areas
Sponsors
Leads: Azienda USL Reggio Emilia - IRCCS

This content was sourced from clinicaltrials.gov