RecruitingNCT06167603

Exploring Brain Molecular Imaging and Blood Biomarkers in Subjects With Glucocerebrosidase Mutations: Toward a Precision Medicine Approach to Characterize Parkinson's Disease Clinical Trajectories


Sponsor

IRCCS San Raffaele

Enrollment

140 participants

Start Date

Apr 30, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Glucocerebrosidase (GBA) mutations are the most common risk factor for Parkinson's Disease (PD). GBA-related PD(GBA-PD) exhibits a more malignant phenotype as compared to no-carriers. Still, the mechanisms behind the increased malignancy in GBA-PD are not well understood. The definition of biomarkers able to stratify PD clinical trajectories in PD is therefore crucial to identify effective treatments and support diagnosis.The investigators will examine the role of GBA-mutations in accelerating a-synuclein (a-syn) and synaptic pathologies in PD by combining neuroimaging (positron emission tomography-PET), biochemical and clinical features. This will illuminate the pathophysiology underlying GBA-mutations in PD and identify biomarkers for the malignant PD phenotype. Also, the investigators will combine longitudinal clinical and imaging/biochemical features to define a prognostic algorithm for predicting disease faster progression in GBA-PD and monitoring disease trajectories in unaffected GBA carriers.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses specialized brain scans and blood tests to better understand how Parkinson's disease progresses in people who carry a specific gene mutation (in a gene called GBA). The goal is to develop a more personalized approach to predicting and tracking the disease. **You may be eligible if...** - You have been diagnosed with Parkinson's disease - You carry a mutation in the GBA gene (for the genetic group) or have standard Parkinson's disease (for the comparison group) - Your disease has been present for 3 to 7 years **You may NOT be eligible if...** - You have other neurological or serious medical conditions - You have mutations in other Parkinson's-related genes - You are unable or unwilling to undergo an FDG-PET brain scan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTFDG-PET

Among other neuroimaging techniques, FDG-PET represents a unique tool to study the early metabolic alterations associated with neurodegeneration, both at the group and individual subject level.

DIAGNOSTIC_TESTBlood test and clinical examination.

baseline, 12-months and 24 months.


Locations(1)

Neurological Institute Foundation Casimiro Mondino

Pavia, Italy

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NCT06167603


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