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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).
Full description
Overview:
The GENDERIZE-PD study investigates how biological sex influences the progression of Parkinson's disease (PD). This groundbreaking project seeks to uncover sex-specific differences in clinical symptoms, disease progression, and biomarkers to enable more personalized and equitable treatment strategies for men and women. By examining a range of biological, clinical, and imaging data, the study aims to provide a deeper understanding of the disease and identify predictors of progression.
Background and Rationale:
PD is a progressive neurodegenerative disorder characterized by motor symptoms (e.g., tremors, rigidity) and non-motor symptoms (e.g., mood disturbances, sleep problems). The disease affects men nearly twice as often as women, and differences between the sexes have been observed in clinical presentations and treatment responses:
Emerging evidence suggests that biological sex impacts brain structure and function, potentially influencing the course of neurodegenerative diseases like PD. Hormonal factors, such as testosterone and estrogen, play key roles in brain health and disease susceptibility. This study seeks to clarify these sex-based differences by analyzing clinical, biological, and neuroimaging data.
Objectives:
The study is designed to achieve the following:
Study Design:
This is a multicenter, observational, prospective, case-control study with a longitudinal follow-up of 18 months. The research involves three Italian centers:
Study Phases:
Participants:
Procedures:
Participants will undergo:
Outcome Measures:
Significance:
This study addresses critical gaps in understanding sex-based differences in PD. By integrating clinical, biological, and imaging data, the results could:
Funding and Ethical Considerations:
The study is funded by the European Union's NextGenerationEU initiative and the Italian Ministry of University and Research (PRIN). It adheres to the Declaration of Helsinki, Good Clinical Practice guidelines, and all relevant regulatory standards. Written informed consent will be obtained from all participants before enrollment.
Implications for Future Research:
Findings from the GENDERIZE-PD study will inform the design of sex-specific clinical trials and potentially contribute to the development of disease-modifying therapies. By considering sex as a key biological variable, this research aims to set a new standard for inclusivity and precision in PD care.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Patients with Parkinson's Disease:
Healthy controls:
-Age: 18-80 years old Able to give informed consent
Exclusion criteria
Healthy controls:
210 participants in 2 patient groups
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Central trial contact
Roberta Balestrino, MD, PhD; Federica Agosta
Data sourced from clinicaltrials.gov
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