Prevent Cognitive Decline in GBA-associated Parkinson's Disease
France, Germany, Italy120 participantsStarted 2025-12
Plain-language 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.
Who can participate
Age range35 Years – 80 Years
SexALL
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Inclusion criteria
✓. Diagnosis of PD according to MDS-Criteria.
✓. Known heterozygous severe GBA mutation (based on PD-related pathogenicity).
✓-\> In case of slow recruitment after 6 months, inclusion of the GBA risk variant E326K as back-up strategy is possible (based on PD-related pathogenicity). This will be communicated by the sponsor beforehand.
✓. MoCA ≥ 21.
✓. HY in dopaminergic ON ≤3.
✓. 35 to 80 years of age at the time of signing the Informed Consent.
✓. 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
✕. Known pathogenic mutation carriers of the following familial PD genes: PRKN, PINK1, DJ1, LRRK2.
✕. Medical history indicating a Parkinsonian syndrome other than sporadic PD (progressive supranuclear palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, primary dystonia).
✕. A diagnosis of a significant CNS disease other than PD.
✕. Previous, current or planned (within next 2 years) treatment with Deep Brain Stimulation (DBS) or ablation with high-intensity focused ultrasound or planned treatment with these within the next 2 years.
. History of brain MRI scan indicative of clinically significant abnormality of prior hemorrhage or ischemic infarction \> 1 cm3, \> 3 lacunar infarctions, vascular encephalopathy with white matter lesions according to Fazekas grade III. Clinical routine brain MRI scan must be available within 2 years before Screening.
✕. Concomitant disease or condition, or treatment thereof that could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study or interfere with the participant's ability to comply with study procedures or abide by study restrictions, or with the ability to interpret safety data, including:
✕. Autoimmune disease (however, well controlled conditions such as quiescent rheumatoid arthritis \[RAS\], controlled type I diabetes, or mild-to-moderate psoriasis not requiring systemic medications may be acceptable after discussion with Sponsor).
✕. History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, non-metastatic prostate cancer, or Stage I uterine cancer.