LRRK2, GBA and Other Genetic Biomarkers in Eastern European (Ashkenazi) Jews With and Without Parkinson's Disease

Parkinson Disease Clinical Trial

— BioPD  

Official title:

Dissecting Oligogenic Biomarkers in Ashkenazi Jews With Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04668898
• Other study ID #: GCO 17-1846
• Secondary ID: 1U01NS107016-01A
• Status: Recruiting
• Start date: April 19, 2019
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Maya Rawal, MS, CGC
• Phone: 212-844-8373
• Email: Maya.Rawal[@]mountsinai.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Single site observational study focused on elucidating the genes and biochemical pathways involved in causing Parkinson disease.

Description:

This single site study, is enrolling Parkinson disease (PD) patients and their family members and is limited to participants of Ashkenazi (Eastern European) Jewish descent with GBA and LRRK2 mutations, or with 3 or more family members with PD. Follow-up will be for three years. Participants must be in the New York City area yearly and willing to come to Mount Sinai Downtown for yearly 2 hour study visits which include obtaining personal medical and family history information, blood, urine and spinal fluid samples, neurological exam and neuropsychiatric testing. De-identified data and samples will be securely stored at a central NIH-run repository for access by other researchers. Spinal fluid collection is encouraged but optional.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Parkinson disease patients and their family members and is limited to participants of Ashkenazi (Eastern European) Jewish descent with GBA and LRRK2 mutations, or with 3 or more family members with PD

• Participants must be local to the New York City area and willing to come to Mount Sinai Downtown for annual 2 hour study visits which include obtaining personal medical and family history information, blood, urine and spinal fluid samples, neurological exam and neuropsychiatric testing. Spinal fluid collection is encouraged but optional.

Exclusion Criteria:

-Patients who do not have Parkinson disease or family members of Ashkenazi (Eastern European) Jewish descent who either has a GBA or LRRK2 mutations OR who has 3 or more family members with PD.

Related Conditions & MeSH terms

• GBA Gene Mutation
• LRRK2
• Parkinson Disease

Locations

Country	Name	City	State
United States	Mount Sinai-- Downtown Union Square	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Massachusetts General Hospital, National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elucidate blood-based genetic biomarkers in Parkinson's disease	Discovery and validation of new blood-based genetic biomarkers (both DNA and expression-based) for Parkinson's disease	five years