A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease
Status:
Completed
Trial end date:
2020-09-10
Target enrollment:
Participant gender:
Summary
This multi-center, randomized, double-blind, placebo-controlled parallel-group study will
evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety
and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants will be
randomized to receive subcutaneous (SC) injections of either gantenerumab or placebo.
Participants who consent to be part of the sub study will undergo positron emission
tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is
104 weeks in Part 1, with an option for an additional up to 2 years of treatment in Part 2,
followed by an open-label extension (Part 3) until July 2020.
The dosing for Parts 1 and 2 was stopped after a planned futility interim analysis showed a
low probability of meeting the primary outcome measure with the doses studied. The study has
converted to open-label to investigate higher gantenerumab doses.