NCT07187843Recruiting
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
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 3 Sept 2025
- Start date
- 4 Sept 2024
- Primary completion date
- 30 Oct 2025
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Diseases
- Parkinson disease
- NCT number
- NCT07187843
What you commit to
- Study type: Observational
- Planned participants: 150
- From 4 Sept 2024 to the primary completion date, 30 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Participant under 18 years of age.
Other
- Inability to express free and informed consent.
- Patient with a doubtful diagnosis.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda USL IRCCS di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.