- Prevent Cognitive Decline in GBA-associated Parkinson’s Disease — Recruiting • Phase II • Neurology • NCT07055087.
- Treatment being tested: Prasinezumab, a monoclonal antibody, is being evaluated for its ability to slow or prevent cognitive decline in patients with Parkinson's disease who carry severe GBA gene mutations.
- Patient eligibility overview: This proof-of-concept trial targets a specific genetic subgroup—individuals with Parkinson's disease carrying severe GBA mutations—representing a distinct phenotype with accelerated disease progression and earlier cognitive impairment.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
This is a proof-of-concept trial to investigate the efficacy of prasinezumab to slow or prevent cognitive decline in people with Parkinson's disease carrying a severe mutation in the GBA (glucocerebrosidase) gene. The duration of the intervention per patient will be 104 weeks with monthly infusions. The investigators plan to enroll 120 participants (60 participants per treatment arm). This study will be conducted across Europe in the following countries: France, Germany, Italy, Luxembourg, Spain, Sweden, UK.
- : 1. Diagnosis of PD according to MDS-Criteria. 2. Known heterozygous severe GBA mutation (based on PD-related pathogenicity) as well as patients carrying the GBA risk variant E326K. 3. MoCA ≥ 21. 4. HY in dopaminergic ON ≤3. 5. 35 to 80 years of age at the time of signing the Informed Consent. 6. Able and willing to provide written informed consent and to comply with the study protocol according to the International Council for Harmonization (ICH) and local regulations.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.