NCT07474779Not yet recruiting

Understanding Alpha-Synuclein Spread in Parkinson's Disease Through Blood Biomarkers and Neuroimaging

From Genes to Virtual Brain: Defining the Pathogenic Mechanisms Promoting Alfa-synuclein Seeding and Spreading in Parkinson's Disease.

Source: ClinicalTrials.gov · Last updated 1 May 2026

Brief summary (registry, in English)

The project aims to investigate how abnormal accumulation of alpha synuclein and its interaction with tau influence brain function across the Parkinson's disease (PD) spectrum, with particular focus on individuals carrying GBA1 mutations. This interventional, monocentric, cross sectional study includes patients with PD, individuals with idiopathic REM sleep behavior disorder, and participants without PD. All enrolled subjects will undergo clinical and neuropsychological assessments, blood based biomarker analyses related to neurodegeneration, synaptic and mitochondrial function, and multimodal brain MRI to evaluate brain structure, white matter integrity, and functional connectivity. The study aims to: * characterize the relationship between alpha synuclein/tau pathology and synaptic mitochondrial dysfunction; * identify biomarker and connectivity signatures across disease stages and genetic backgrounds; * integrate preclinical, clinical, biological, and imaging data to support the development of mechanistic models of alpha synuclein propagation. In parallel, preclinical studies in GBA PD mouse models and wild type mice will be used to investigate how changes in PD-related pathology (alpha-synuclein and tau) relates to behavior, brain imaging alterations and mitochondrial, axonal and synaptic damage. Animal model will also aid the validation of a new PET tracer that targets alpha synuclein (i.e., \[¹⁸F\]Syntacasyn). Together, human and preclinical studies are designed to provide a translational framework integrating molecular changes with brain network alterations and clinical heterogeneity in PD.

Status (registry): Not yet recruiting
Study type: Interventional
Enrollment: 160 (estimated)
First submitted: 6 Mar 2026
Start date: 11 May 2026
Primary completion date: Dec 2028
Lead sponsor: University of Pavia
Diseases: Parkinson disease
NCT number: NCT07474779

What you commit to

Study type: Interventional
Planned participants: 160
From 11 May 2026 to the primary completion date, Dec 2028
2 sites 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.

Other illness

Diagnosis of dementia according to DSM-5 criteria;
Presence of other neurological disorders and/or essential tremor;
Presence of systemic inflammatory or infectious diseases, autoimmune diseases, or malignant tumors at the time of enrollment.
Presence of systemic inflammatory or infectious diseases, autoimmune diseases, or malignant tumors at the time of enrollment;
Diagnosis of dementia according to DSM-5 criteria.
Presence of systemic inflammatory or infectious diseases, autoimmune diseases, or malignant tumors at the time of enrollment;
Diagnosis of dementia according to DSM-5 criteria.

Other

Diagnosis of atypical and/or secondary parkinsonism;
Diagnosis of atypical and/or secondary parkinsonism;
Diagnosis of atypical and/or secondary parkinsonism;

Who the study is looking for

Diagnosis of PD according to MDS-PD criteria and, for the GBA-PD group, presence of heterozygous GBA mutations (with a balanced distribution of severe, risk, mild, and complex variants);
Disease duration between 3 and 7 years;
Disease stage according to Hoehn \& Yahr ≤ 3;
Absence of mutations in other known genes associated with PD susceptibility;
Age \> 18 Years;
Ability to understand and voluntarily sign informed consent and to comply with study procedures.
Age \> 18 Years;
Ability to understand and voluntarily sign informed consent and to comply with study procedures;
No diagnosis of PD or other neurological disorders;
Presence of a heterozygous GBA mutation for the GBA-nonPD group and absence of such mutation for control subjects (nonGBA-nonPD);
Absence of mutations in other known genes associated with PD susceptibility.
Diagnosis of idiopathic REM Sleep Behavior Disorder according to ICSD-3;
Age \> 18 Years;
Ability to understand and voluntarily sign informed consent and to comply with study procedures;
No diagnosis of PD or other neurological disorders;
Presence of a heterozygous GBA mutation for the GBA-iRBD group and absence of such mutation for the nonGBA-iRBD group;
Absence of mutations in other known genes associated with PD susceptibility.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Neurological Institute Foundation Casimiro Mondino Coordinator of this site? Confirm its status	Pavia	Italy	Unknown status
University of Pavia Coordinator of this site? Confirm its status	Pavia	Italy	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.