Efficacy and Safety 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
- NCT03444870
- Run by
- Hoffmann-La Roche
- People needed
- 1053
- Starts
- 2018-06-06
- Expected to finish
- 2023-02-17
- Last updated by the study team
- 2024-01-30
Who can join
Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Global Clinical Trials; Irvine, CA — Irvine, California, United States
- Sutter Medical Group, Neurology — Sacramento, California, United States
- Syrentis Clinical Research — Santa Ana, California, United States
- California Neuroscience Research Medical Group, Inc — Sherman Oaks, California, United States
- Research Center for Clinical Studies, Inc. — Norwalk, Connecticut, United States
- JEM Research LLC — Atlantis, Florida, United States
- Bradenton Research Center — Bradenton, Florida, United States
- Brain Matters Research, Inc. — Delray Beach, Florida, United States
- Alzheimer?s Research and Treatment Center — Wellington, Florida, United States
- Columbus Memory Center — Columbus, Georgia, United States
- Center for Advanced Research & Education — Gainesville, Georgia, United States
- Southern Illinois University, School of Medicine — Springfield, Illinois, United States
- Fort Wayne Neurological Center — Fort Wayne, Indiana, United States
- Via Christi Research — Wichita, Kansas, United States
- Precise Research Centers — Flowood, Mississippi, United States
- University of Mississippi Medical Center — Jackson, Mississippi, United States
- Advanced Memory Research Institute of NJ — Toms River, New Jersey, United States
- Neurological Associates of Long Island, PC — Lake Success, New York, United States
- Columbia University Medical Center — New York, New York, United States
- Ohio State University; College of Medicine — Columbus, Ohio, United States
- Abington Neurological Associates — Abington, Pennsylvania, United States
- The Clinical Trial Center, LLC — Jenkintown, Pennsylvania, United States
- Drexel University; College of Medicine — Philadelphia, Pennsylvania, United States
- Coastal Neurology — Port Royal, South Carolina, United States
- Center for Neurosciences — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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