Effect of Biological Sex on Multimodal Biomarkers of Disease Progression in Patients with Parkinson's Disease

Brief summary (registry, in English)

The GENDERIZE-PD study is a research project to understand how biological sex affects the progression of Parkinson's disease (PD). PD is a brain disorder that causes both movement and non-movement symptoms. Researchers aim to identify differences between men and women in how the disease progresses and in the biomarkers (biological indicators) related to the condition. Study Goals: Identify differences by sex in how PD develops and progresses, using clinical assessments, brain scans, and blood tests. Find predictors of disease progression that may help create personalized treatments for men and women. Study Details: Type of Study: Observational, with additional procedures (e.g., blood tests and brain scans). Participants: 120 people with early-stage PD (60 men, 60 women) diagnosed within the last 3 years. 90 healthy participants (caregivers or relatives) for comparison. Procedures: Clinical exams and questionnaires about movement and non-movement symptoms (like sleep, mood, and fatigue). Blood tests to measure hormone levels. Brain imaging to study changes in structure and activity. Timeline: Participants will be followed for 18 months, with evaluations at 0, 6, 12, and 18 months. Why This Study is Important: Men and women often experience PD differently. For example: Men are more likely to have memory and thinking problems. Women may develop movement side effects from treatments more often. Understanding these differences can lead to: Improved care plans tailored to men and women. Better treatment outcomes by focusing on sex-specific factors. Who Can Join: Adults aged 18-80 with early-stage PD or healthy individuals willing to provide blood samples and undergo brain imaging. Exclusions include women not in menopause and people with certain medical or other health conditions. Study Locations: The study is conducted at three centers in Italy: San Raffaele Scientific Institute - Milan (led by Prof. Federica Agosta). University of Campania "Luigi Vanvitelli" - Naples (led by Prof. Alessandro Tessitore). University "Magna Graecia" - Catanzaro (led by Prof. Gennarina Arabia).

What you commit to

• Study type: Observational
• Planned participants: 210
• From 1 Feb 2025 to the primary completion date, 31 Oct 2025
• No sites listed in no 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.

Who the study is looking for

Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov