Following early Parkinson's disease patients to compare two disease types
Studies symptoms and brain-related markers in adults with early Parkinson's disease over time.
Key facts
- Who runs it
- Azienda USL Reggio Emilia - IRCCS
- Where
- Reggio Emilia, ItalySee the site
- Trial code
- Registry title
- Study of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Brain-first and Body-first PD
- Status
- Recruiting
- People taking part
- 150 people, planned
- Started
- 4 Sept 2024
- Expected to end
- May 2031
- Type of study
- Observational, 2 groups
- Treatments tested
- Clinical assessments
- Phenotypic classification
- Record updated
- 23 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Parkinson's disease. People are grouped into brain-first or body-first types, based on sleep behavior and scan results.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Parkinson's disease diagnosed by the MDS Clinical Diagnostic Criteria. The summary says early-stage disease.
- Biomarker or test result
- Brain-first or body-first type is set by REM sleep behavior disorder (found by ambulatory polysomnography), DATSCAN SPECT and myocardial innervation scintigraphy [123I-MIBG].
Main reasons for not taking part
- Cannot give free and informed consent
- Doubtful diagnosis
- Under 18 years of age
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Participant under 18 years of age
- Inability to express free and informed consent
- Patient with a doubtful diagnosis
Where in Italy
- Azienda USL IRCCS di Reggio EmiliaReggio Emilia, ItalyContact: Francesco Cavallieri, MDTaking people
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- 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.
Treatment: Clinical assessments and Phenotypic classification
- 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.
Treatment: Clinical assessments and Phenotypic classification
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Following early Parkinson's disease patients to compare two disease typesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 23 April 2026