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

NCT06790381 | Not Yet Recruiting

• 1 other identifier: GENDERIZE-PD
• Study Type: observational
• Target: 210
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

sex Hormones; Neuroimaging; Biomarkers; Parkinson's Sex differences; Parkinson's progression; non-motor symptoms; motor symptoms

Outcome Measures

Primary Outcomes (1)

• MDS-sponsored revision of the Unified Parkinson's Disease Rating Scale

  The International Parkinson and Movement Disorder Society sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a comprehensive 50 question assessment of both motor and non-motor symptoms associated with Parkinson's

  0,6,12, 18 months

Secondary Outcomes (1)

• Sex hormones (free androgens index)

  Baseline, 12 months

Other Outcomes (16)

• Magnetic resonance imaging

  0,12 months

• (123)I-2β-carbomethoxy-3β-(4-iodophenyl)-N-(3-fluoropropyl)-nortropane ((123)I-FP-CIT) SPECT.

  baseline

• Unified Dyskinesia Rating Scale (UDysRS)

  0,6,12,18 months

Study Arms (2)

Patients

Patients with Parkinson's Disease

controls

Healthy controls

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Parkinson's Disease and healthy controls

You may qualify if:

• Patients with Parkinson's Disease:
• Age: 18-80 years old
• Idiopathic early-stage Parkinson's Disease (≤3 years of disease)
• Stage ≤2.5 on the Hoehn\&Yahr scale Able to give informed consent
• Healthy controls:
• Age: 18-80 years old Able to give informed consent

You may not qualify if:

• Patients with Parkinson's Disease:
• Presence of Parkinson's Disease dementia
• Presence of major depression or other dysthymic disorders according to DSM-IV criteria
• Women not in menopause (menopause is a point in time 12 months after a woman's last period)
• Any other relevant neurological or medical condition
• Healthy controls:
• Women not in menopause (menopause is a point in time 12 months after a woman's last period)
• Any other relevant neurological or medical condition

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Università della Campania Luigi Vanvitelli: collaborator
• University of Catanzaro: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Federica Agosta, MD,PhD

  IRCCS San Raffale, Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta Balestrino, MD, PhD

CONTACT

00390226437680; balestrino.roberta@hsr.it

Federica Agosta

CONTACT

agosta.federica@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FULL PROFESSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 24, 2025
• Study Start: February 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01