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LRRK2 (Leucine-Rich Repeat Kinase 2) Parkinson's Disease Fingerprint

No phase Interventional Parkinsons Disease (PD) LRRK2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The interventions of the study are the study of blood biomarkers and neuroimaging and neurophysiological data.
Who it may be relevant to
Registry conditions: Parkinsons Disease (PD), LRRK2. Basic parameters: 30 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

LRRK2 Associated Parkinson's Disease: Definition of a Clinical, Molecular and Neurophysiological Fingerprint

Overview

The goal of this interventional monocentric study is to identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis and deep clinical phenotyping. Patients who meet the inclusion criteria, after signing the informed consent form will be clinically evaluated by a neurologist expert in movement disorders. Eventually, patients will undergo a blood sample collection, a brain MRI, and a high density EEG. All data will be collected using an ad hoc electronic Case Report Form (CRF) developed for the study

Interventions

  • Diagnostic test The interventions of the study are the study of blood biomarkers and neuroimaging and neurophysiological data
    * Blood sample collection and markers analysis * Brain 1.5 T MRI * High density EEG

Primary outcome measures

  • 1) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping. [Time frame: Through the study completion, about 3 years]
  • 2) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping. [Time frame: Through the study completion, about 3 years]
  • 3) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping. [Time frame: Through the study completion, about 3 years]
  • 4) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping. [Time frame: Through the study completion, about 3 years]
  • 5) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping. [Time frame: Through the study completion, about 3 years]
  • 6) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping. [Time frame: Through the study completion, about 3 years]
  • 7) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping. [Time frame: Through the study completion, about 3 years]
  • 8) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping. [Time frame: Through the study completion, about 3 years]
  • 9) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping. [Time frame: Through the study completion, about 3 years]
  • 10) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping [Time frame: Through the study completion, about 3 years]
Secondary outcome measures (2)
  • 1) Mechanistic Modeling of LRRK2-Associated Parkinson's Disease [Time frame: Through study completion, about 3 years]
  • 2) Mechanistic Modeling of LRRK2-Associated Parkinson's Disease [Time frame: Through the study completion, about 3 years]

Eligibility criteria

Inclusion criteria

  • age 30-80 years,
  • clinically established diagnosis of PD according to the Movement Disorders Society (MDS) diagnostic criteria,
  • Hoehn \& Yahr (H\&Y) stage between 1 and 3,
  • 10 patients with a LRRK2 associated parkinsonism and 10 with sporadic PD tested with a NGS panel and MLPA for PD associated genes,
  • ability to provide informed consent.

Exclusion criteria

  • Active or history of other neurological disorders,
  • active infectious disease or history within the previous 4 weeks,
  • continuative therapy (at least 1 week) with NSAIDs or steroids within the previous 12 weeks,
  • active malignancy, autoinflammatory or autoimmune diseases or history within the previous 3 years;
  • alcohol or drug abuse or dependence
  • any contraindication to the execution of the MRI (including claustrophobia).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07681219 · 27556

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗