Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
Public ClinicalTrials.gov record NCT03444870. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03444870
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,053 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 6, 2018 (Actual)
- Primary completion
- Dec 28, 2022 (Actual)
- Completion
- Feb 17, 2023 (Actual)
- Last update posted
- Jan 30, 2024
2018 – 2023
United States locations
- U.S. sites
- 33
- U.S. states
- 18
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Center for Neurosciences | Tucson | Arizona | 85718 | — |
| Global Clinical Trials; Irvine, CA | Irvine | California | 92614 | — |
| Sutter Medical Group, Neurology | Sacramento | California | 95816 | — |
| Syrentis Clinical Research | Santa Ana | California | 92705 | — |
| California Neuroscience Research Medical Group, Inc | Sherman Oaks | California | 91403 | — |
| Research Center for Clinical Studies, Inc. | Norwalk | Connecticut | 06851 | — |
| JEM Research LLC | Atlantis | Florida | 33462 | — |
| Bradenton Research Center | Bradenton | Florida | 34205 | — |
| Brain Matters Research, Inc. | Delray Beach | Florida | 33445 | — |
| Alzheimer?s Research and Treatment Center | Wellington | Florida | 33414 | — |
| Columbus Memory Center | Columbus | Georgia | 31909 | — |
| Center for Advanced Research & Education | Gainesville | Georgia | 30501 | — |
| Southern Illinois University, School of Medicine | Springfield | Illinois | 62702 | — |
| Fort Wayne Neurological Center | Fort Wayne | Indiana | 46805 | — |
| Via Christi Research | Wichita | Kansas | 67214 | — |
| Precise Research Centers | Flowood | Mississippi | 39232 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Advanced Memory Research Institute of NJ | Toms River | New Jersey | 08755 | — |
| Neurological Associates of Long Island, PC | Lake Success | New York | 11042 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Ohio State University; College of Medicine | Columbus | Ohio | 43210 | — |
| Abington Neurological Associates | Abington | Pennsylvania | 19001 | — |
| The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | 19046 | — |
| Drexel University; College of Medicine | Philadelphia | Pennsylvania | 19102 | — |
| Coastal Neurology | Port Royal | South Carolina | 29935 | — |
| Senior Adults Specialty Research | Austin | Texas | 78757 | — |
| Neurology Consultants of Dallas; Research Department | Dallas | Texas | 75243 | — |
| Wasatch Clinical Research, LLC | Salt Lake City | Utah | 84107 | — |
| University of Virginia | Charlottesville | Virginia | 22906 | — |
| Sentara Neurology Specialists | Norfolk | Virginia | 23507 | — |
| Neurological Associates, Inc. | Richmond | Virginia | 23229 | — |
| National Clinical Research Inc.-Richmond | Richmond | Virginia | 23294 | — |
| UW Wisconsin-Madison | Madison | Wisconsin | 53705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 139 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03444870, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 30, 2024 · Synced Oct 31, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03444870 live on ClinicalTrials.gov.