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 range
35 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically focused on GBA-associated Parkinson's Disease — how would my doctor confirm whether my Parkinson's is linked to a GBA gene mutation, and would I need genetic testing before this could even be considered?
2Since this is a Phase 2 trial and it hasn't started recruiting yet, what does that mean for how much is already known about the safety and effectiveness of whatever treatment is being tested here?
3The trial is measuring cognitive decline using something called the Parkinson's Disease Cognitive Composite Score — does my doctor think my current cognitive status would be relevant to whether I might be a candidate, and what does that score actually track over time?
4Because this trial isn't recruiting yet, is there a standard treatment approach for GBA-associated Parkinson's that my doctor would recommend pursuing now, and how would starting that affect my options for joining this study later?
5What would participation in a trial like this actually look like in terms of visits, monitoring, and time commitment, and are there other ongoing trials targeting cognitive symptoms in Parkinson's that my doctor thinks might be worth comparing this one to?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.