NCT07055087

Prevent Cognitive Decline in GBA-associated Parkinson's Disease

A Randomized, Double-blind, Placebo-controlled, 104-week Proof-of-concept Study to Evaluate the Efficacy of Intravenous Prasinezumab in Participants With Parkinson's Disease Carrying a Severe Mutation in the GBA Gene

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a proof-of-concept (POC) prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial to investigate the efficacy of the intravenously (IV) applied monoclonal anti-α-synuclein antibody prasinezumab to slow or prevent cognitive decline in people with Parkinson's disease (PD) carrying a severe mutation in the GBA (glucocerebrosidase) gene (PDGBA\_severe). 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. Randomization will be 1:1 prasinezumab (1500mg) versus placebo (saline infusion). Randomization will be stratified by sex, age group (\< 55 years vs ≥ 55 years), and baseline Montreal Cognitive Assessment (MoCA) (≤ 25) to ensure balance of these factors between the prasinezumab and placebo group. Participants, aged 35 to 80 years, diagnosed with PD and carrying a known severe mutation in the GBA gene according to the definition for PD (see Supplemental Table 1 for a list of applicable mutations). MoCA at Screening must be ≥ 21.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Prasinezumab	Prasinezumab 1500 mg monthly infusion
DRUG	Sodium Chloride	Saline infusion (0,9 % sodium chloride) monthly infusion

Timeline

• Start date: 2025-12-01
• Primary completion: 2030-12-01
• Completion: 2031-05-01
• First posted: 2025-07-08
• Last updated: 2025-07-08

Locations

8 sites across 7 countries: France, Germany, Italy, Luxembourg, Spain, Sweden, United Kingdom