Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Alzheimer Disease
In brief
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 facts
- Study ID
- NCT03443973
- Run by
- Hoffmann-La Roche
- People needed
- 975
- Starts
- 2018-08-22
- Expected to finish
- 2022-11-28
- Last updated by the study team
- 2024-01-17
Who can join
Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Barrow Neurological Institute — Phoenix, Arizona, United States
- Banner Sun Health Research Insitute — Sun City, Arizona, United States
- Health Initiatives Research, PLLC — Fayetteville, Arkansas, United States
- Fullerton Neurology and Headache Center — Fullerton, California, United States
- Neurology Center of North Orange County — Fullerton, California, United States
- Irvine Center for Clinical Research — Irvine, California, United States
- Desert Valley Research — Redlands, California, United States
- Southern California Research LLC — Simi Valley, California, United States
- Yale University School Of Medicine — New Haven, Connecticut, United States
- Georgetown University Medical Center — Washington D.C., District of Columbia, United States
- Accel Research Sites - CRU Tampa — Bradenton, Florida, United States
- ClinCloud, LLC — Maitland, Florida, United States
- Optimus U Corp — Miami, Florida, United States
- Allied Biomedical Research Institute, Inc — Miami, Florida, United States
- Renstar Medical Research — Ocala, Florida, United States
- Progressive Medical Research — Port Orange, Florida, United States
- Intercoastal Medical Group — Sarasota, Florida, United States
- Infinity Clinical Research, LLC — Sunrise, Florida, United States
- Axiom Clinical Research of Florida — Tampa, Florida, United States
- Emory University — Atlanta, Georgia, United States
- Rush Alzheimer's Disease Cntr. — Chicago, Illinois, United States
- American Health Network Institute, LLC — Avon, Indiana, United States
- Brigham and Womens Hospital; Center for Alzheimer Research & Treatment — Boston, Massachusetts, United States
- ActivMed Practices and Research — Haverhill, Massachusetts, United States
- Banner Alzheimer?s Institute — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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