Prevent Cognitive Decline in GBA-associated Parkinson's Disease

Sponsor
University Hospital Tuebingen
Study ID
NCT07055087
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Prasinezumab — DRUG
    Prasinezumab 1500 mg monthly infusion
  • Sodium Chloride — DRUG
    Saline infusion (0,9 % sodium chloride) monthly infusion

Study Details

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.

Key Dates

Start date
Dec 31, 2025
Status verified
May 2025
Primary completion
Dec 31, 2030
Completion
May 31, 2031

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Prasinezumab
    prasinezumab 1500 mg monthly infusion
  • Placebo Comparator: Sodium chloride 0,9% infusion
    saline infusion (0,9 % sodium chloride) monthly infusion

Primary Outcome Measure

Parkinson's Disease Cognitive Composite Score (PDCCS) [ Time Frame: week 104 ]

Central Contacts

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