Axial and cognitive symptoms and biomarkers in brain‑first versus body‑first Parkinson's disease
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
Run by Azienda USL Reggio Emilia - IRCCS · NCT07187843 · Data updated 2026-11-12
This project will test whether clinical exams, sleep testing, heart and brain scans, and blood/CSF biomarkers can distinguish brain‑first from body‑first early Parkinson's patients and predict worsening of balance and thinking problems.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Azienda USL Reggio Emilia - IRCCS Government |
| Locations | 1 site (Reggio Emilia) |
| Status | Recruiting |
| Started | September 4, 2024 |
| Main results expected | October 30, 2025 |
| Study ends | May 2031 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT07187843 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with a clinical diagnosis of Parkinson's disease according to MDS criteria, able to give informed consent and able to undergo sleep studies and imaging, are ideal candidates.
✕Probably not a fit
Patients with an unclear or doubtful diagnosis, those under 18, those unable to consent, or those who cannot complete required sleep testing or imaging are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational cohort will enroll early Parkinson's patients seen at the Movement Disorders Center of AUSL‑IRCCS Reggio Emilia for detailed clinical, imaging, and biomarker characterization. Participants will undergo ambulatory polysomnography to identify REM sleep behavior disorder, DAT SPECT and 123I‑MIBG myocardial scintigraphy for dopaminergic and autonomic innervation, and blood/CSF testing for neurodegeneration and neuroinflammation markers. Patients will be classified as brain‑first or body‑first based on sleep and imaging data, with a focus on tracking axial (postural/gait) and cognitive symptom patterns. The goal is to link phenotype, imaging, and molecular markers to improve early stratification and inform precision medicine approaches.
Why it matters
Potential benefit: If successful, the findings could allow earlier and more accurate classification of Parkinson's subtypes, improving prognosis and guiding more targeted future therapies.
How similar studies have gone: Previous work on the brain‑first versus body‑first hypothesis and multimodal biomarker profiling has shown promising but still preliminary results, so this approach is supported by emerging evidence rather than definitive proof.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, Italy Recruiting
Study contacts
- Study coordinator: Francesco Cavallieri, MD
- Email: francesco.cavallieri@ausl.re.it
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.