A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease
This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 116. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.
Key Inclusion criteria:
Key Exclusion criteria:
Exclusion for Open-Label Extension (OLE):
Boston, Massachusetts 02115, United States
Omaha, Nebraska 68198-8440, United States
Cleveland, Ohio 44195, United States
Houston, Texas 77030, United States
Caba, C1405BCK, Argentina
Capital Federal, C1427CCP, Argentina
Monterrey, Nuevo León 64460, Mexico
?cinawa, 59-330, Poland
Bia?ystok, 15-756, Poland
Siemianowice ?l?skie, 41-100, Poland
Wroc?aw, 53-659, Poland
Mölndal, 431 41, Sweden
Cheltenham, GL53 9DZ, United Kingdom
Chertsey, KT16 9AU, United Kingdom
Crowborough, TN6 1HB, United Kingdom
Sheffield, S10 2JF, United Kingdom