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

Inclusion Criteria2

  • PD diagnosis according to MDS-PD criteria and for GBA-PD group, presence of heterozygous GBA mutations;
  • disease duration 3-7years.

Exclusion Criteria3

  • other neurological or systemic diseases;
  • presence of mutations in another PD gene;
  • impossibility or unwillingness to perform FDG-PET.

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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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