Study of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Brain-first and Body-first PD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-04

Study Completion Date

2031-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Autonomic, Imaging and Genetic Markers for Parkinson-related Dementia : Longitudinal Assessment of a PD Cohort.

NCT06156917

Parkinson Disease

COMPLETED

Early Biomarkers of Neurodegeneration in Parkinsonian Syndromes

NCT06155942

Parkinson Disease Progressive Supranuclear Palsy

NOT_YET_RECRUITING NA

Free-living Monitoring of Parkinson's Disease Using Smart Objects

NCT05830253

Parkinson Disease

COMPLETED

Biomarkers in Parkinsonian Syndromes

NCT06501469

Parkinson Disease Progressive Supranuclear Palsy Multiple System Atrophy +2 more

RECRUITING

Study for the Early Diagnosis of Parkinson's Disease

NCT02283073

Parkinson's Disease, Idiopathic

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease, affecting up to 1% of individuals over the age of 60. While treatment remains symptomatic and no disease-modifying therapies are currently available, increasing research efforts are focusing on precision medicine approaches and the identification of disease subtypes that may guide prognosis and therapy.

Historically, PD patients have been classified according to motor (tremor-dominant, akinetic-rigid, axial) and non-motor features (sleep disturbances, autonomic dysfunction, mood disorders, fatigue, pain, weight loss, cognitive impairment). Genetic classifications have also been introduced, with approximately 10-15% of patients carrying mutations such as GBA or LRRK2, which are associated with earlier onset and potentially more aggressive disease.

In the early 2000s, Braak and colleagues proposed a neuropathological staging system in which α-synuclein pathology progresses in a stereotypical pattern from peripheral to central structures. More recent clinical and pathological evidence, however, has challenged this model and led to the proposal of two distinct subtypes: Brain-First and Body-First. In Brain-First PD, pathology begins in the central nervous system and spreads to the autonomic system; in Body-First PD, pathology originates in peripheral structures such as the enteric nervous system, propagating rostrally to involve the brain. REM sleep behavior disorder (RBD) has emerged as a clinical marker of the Body-First subtype.

This study will systematically characterize patients with early-stage PD, combining detailed clinical evaluation with instrumental assessments including neuroimaging and blood-based biomarkers. In particular, the project will investigate whether Brain-First and Body-First phenotypes differ in terms of:

* Clinical progression (with focus on axial and cognitive symptoms).
* Neurodegeneration biomarkers, including neurofilament light chain.
* Neuroinflammation markers, such as immune responses to α-synuclein, interferon-gamma, and interleukin-5.

The overarching goal is to identify biological and clinical markers that distinguish PD subtypes, improve early stratification, and support the development of targeted, disease-modifying therapies.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease Parkinsonian Disorders Brain Disease Basal Ganglia Diseases Synucleinopathies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Clinical assessments

Intervention Type OTHER

standardized neurological examination, motor and non-motor symptom scales, cognitive testing, and autonomic symptom questionnaires.

Phenotypic classification

Intervention Type OTHER

patients will be stratified into Brain-First and Body-First phenotypes based on the presence of RBD and instrumental findings.

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.

Clinical assessments

Intervention Type OTHER

standardized neurological examination, motor and non-motor symptom scales, cognitive testing, and autonomic symptom questionnaires.

Phenotypic classification

Intervention Type OTHER

patients will be stratified into Brain-First and Body-First phenotypes based on the presence of RBD and instrumental findings.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clinical assessments

standardized neurological examination, motor and non-motor symptom scales, cognitive testing, and autonomic symptom questionnaires.

Intervention Type OTHER

Phenotypic classification

patients will be stratified into Brain-First and Body-First phenotypes based on the presence of RBD and instrumental findings.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.