✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
PHASE2
Participants
ALL
Age Range
35 Years – 80 Years
About This Trial
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.
Who Can Join?
Inclusion Criteria: 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. Exclusion Criteria: Current or Past Medical History: 1. Known pathogenic mutation carriers of the following familial PD genes: PRKN, PINK1, DJ1, LRRK2. 2. Medical history indicating a Parkinsonian syndrome other than sporadic PD (progressive supranuclear palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, primary dystonia). 3. A diagnosis of a significant CNS disease other than PD. 4. Previous, current or planned (within next 2 years) treatment with Deep Brain…
⚠ Always speak to your doctor before applying to any clinical trial.