Observational Assessment of Clinical and Genetic Risk Factors Associated with GBA1-Associated Parkinson's Disease Clinical Progression: A genetic Analysis and Retrospective Study

Observational Assessment of Clinical and Genetic Risk Factors Associated with GBA1-Associated Parkinson's Disease Clinical Progression: A genetic Analysis and Retrospective Study - Clinical and Genetic Risk in GBA-PD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46323

Enrollment

350

Registered

2018-10-10

Start date

2019-06-04

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GBA-Parkinson's disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Signed informed consent prior to any study-mandated procedure. 2. Minimum age of 18 years. 3. Clinical diagnosis of Parkinson*s disease at least 6 months prior to screening, confirmed by a Movement Disorder*s Neurologist. 4. Mutation(s) in the glucocerebrosidase GBA1 gene. Reference Appendix A for a list of GBA1 mutations.

Exclusion criteria

Exclusion criteria: N.A.

Design outcomes

Primary

Measure	Time frame
Based on multiple parameters, the following compound measurements are constructed: - Parkinsons disease Progression Rate Inventory (PD-PRI) - GBA1 genotype and PD associated SNPs - Parkinsons Risk Score (PRS) - Rate of disease progression as rated by a clinical expert: Slow, Intermediate, Fast The endpoints are the analyses of the associations between: genetic factors and phenotypic factors * genetic factors and the rate of disease progression as rated by a Movement Disorder Neurologist * genetic factors and a data-driven algorithm based on phenotypic characteristics	—

Measure

Time frame

Based on multiple parameters, the following compound measurements are constructed: - Parkinson*s disease * Progression Rate Inventory (PD-PRI) - GBA1 genotype and PD associated SNPs - Parkinson*s Risk Score (PRS) - Rate of disease progression as rated by a clinical expert: Slow, Intermediate, Fast The endpoints are the analyses of the associations between: * genetic factors and phenotypic factors * genetic factors and the rate of disease progression as rated by a Movement Disorder Neurologist * genetic factors and a data-driven algorithm based on phenotypic characteristics

—

Secondary

Measure	Time frame
N.A.	—

Countries

Netherlands

Outcome results