PreCoDe: prasinezumab in GBA carriers

The research record

This is the project's file for this landmark, as written and checked. Sources are listed at the end; anything not yet confirmed is marked "Not yet verified".

Who

University Hospital Tübingen (sponsor); trial name PreCoDe; NCT07055087; EU CTIS number 2024-513496-40-00. Study sites planned in France, Germany, Italy, Luxembourg, Spain, Sweden and the UK. The antibody comes from Roche (landmark 63).

What happened

• Design. A 104-week, randomised, double-blind, placebo-controlled proof-of-concept Phase 2. 120 people (60 per arm) with Parkinson's and a known severe GBA mutation (the milder E326K variant is a back-up if recruitment is slow). Prasinezumab 1,500 mg by monthly infusion, or saline.
• Who is eligible. MoCA (a screening test of thinking) of 21 or more, Hoehn and Yahr stage 3 or lower, aged 35 to 80.
• Main measure. The Parkinson's Disease Cognitive Composite Score at week 104.
• Status. The registry record was last updated on 8 July 2025 and shows "not yet recruiting", estimated start December 2025 (now past, with no update), primary completion December 2030, study completion May 2031 (re-read via API 22 Oct 2026, unchanged; the record may be out of date).
• No results.

Why it moved us toward a cure

GBA carriers, especially those with severe mutations, have more dementia and a harder course (landmark 86). Prasinezumab's phase 2 trials missed their main goals but hinted at slowing of motor decline (landmark 63); this trial tests it in a group chosen by genetics and aimed at thinking skills instead of movement. Its main trial, the 900-person Phase 3, is in landmark 157. Whether GBA carriers respond differently to an anti-synuclein antibody is unknown.

Outcome

Pending. Expected primary completion December 2030 (registry estimate); start not confirmed.

Sources

• ClinicalTrials.gov NCT07055087 (API v2, read 19 Oct 2026)
• Sweep of 2025–26 trials, this project, 19 Oct 2026
• Not yet verified: whether recruitment has begun (a March 2026 briefing from the German Parkinson's society, found only through a search summary and not opened, reportedly gives a summer 2026 start; no sponsor release or paper confirms it); Roche's role in supply; any publication of the protocol; the scientific rationale in the sponsor's own words.