MedTrace Logo

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

NCT06790381 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 210

Last updated 2025-01-24

No results posted yet for this study

Summary

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).

Conditions

  • Parkinson Disease

Sponsors & Collaborators

  • Università della Campania Luigi Vanvitelli

    collaborator UNKNOWN

  • University of Catanzaro

    collaborator OTHER

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Federica Agosta, MD,PhD · IRCCS San Raffale, Milan

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2025-10-31
Completion
2025-10-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06790381 on ClinicalTrials.gov