A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Gantenerumab in Patients With Mild Alzheimer's Disease; Part II: Open-Label Extension For Participating Patients
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Gantenerumab in Patients With Mild Alzheimer's Disease; Part II: Open-Label Extension For Participating Patients
Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer disease. Participants will be randomized to receive either gantenerumab subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE).
A positron emission tomography (PET) imaging substudy will be conducted within the main study. Eligible participants who provide separate informed consent will undergo PET imaging scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain amyloid load over time.
Inclusion Criteria:
PART 2 - All participants who have been randomized and are actively participating in the study are eligible for Part 2
Exclusion Criteria:
PET imaging substudy, in addition to above:
- Prior participation in other research study or clinical care within the last year such that the total radiation exposure would exceed the local or national annual limits
Part 2 Participants who have been discontinued from the study
Kalamazoo, Michigan 49008, United States
Salt Lake City, Utah 84108, United States
Ciudad Autonoma Buenos Aires, C1426ANZ, Argentina
Heidelberg West, Victoria 3081, Australia
Québec, Quebec G1J 1Z4, Canada
Verdun, Quebec H4H 1R3, Canada
Koebenhavn Oe, 2100, Denmark
Berlin, 13125, Germany
Westerstede, 26655, Germany
Modena, Emilia-Romagna 41126, Italy
Gunma, 371-0014, Japan
Hyōgo, 670-0981, Japan
Kazan', 420021, Russia
Kazan', 420101, Russia
Moscow, 119021, Russia
Saint Petersburg, 190103, Russia
Saint Petersburg, 194044, Russia
BArcelon, Barcelona 08034, Spain
Donosti-San Sebastián, Guipuzcoa 20014, Spain
Crowborough, TN6 1HB, United Kingdom