A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy And Safety Study of Crenezumab in Patients With Prodromal to Mild Alzheimer's Disease.
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy And Safety Study of Crenezumab in Patients With Prodromal to Mild Alzheimer's Disease.
This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose. Participants will then have the option to enter the Open Label Extension (OLE) study if eligible. Participants who do not enter the OLE study will have additional follow-up visits at 16 and 52 weeks after the last dose, primarily for safety and also for limited efficacy assessments.
Inclusion Criteria:
Exclusion Criteria:
If considered to be cured or If not being actively treated with anti-cancer therapy or radiotherapy
- Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
Sacramento, California 95817, United States
Albany, New York 12206, United States
Fort Worth, Texas 76107, United States
Heidelberg West, Victoria 3081, Australia
Sofia, 1407, Bulgaria
Hradec Králové, 500 05, Czechia
München, 81675, Germany
Westerstede, 26655, Germany
Nyíregyháza, 4400, Hungary
Milan, Lombardy 20148, Italy
Perugia, Umbria 06129, Italy
Kazan', 420021, Russia
Kazan', 420101, Russia
Moscow, 119021, Russia
Saint Petersburg, 194044, Russia
BArcelon, Barcelona 08034, Spain
L'Hospitalet de Llobregat, Barcelona 08907, Spain
Salamaca, Salamanca 37007, Spain
Mölndal, 431 41, Sweden
Lviv, KIEV Governorate 79021, Ukraine
Kiev, 04112, Ukraine
Kiev, 04114, Ukraine
Chertsey, KT16 0AE, United Kingdom