Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
Public ClinicalTrials.gov record NCT03443973. 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
- NCT03443973
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 975 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
- Aug 22, 2018 (Actual)
- Primary completion
- Sep 23, 2022 (Actual)
- Completion
- Nov 28, 2022 (Actual)
- Last update posted
- Jan 17, 2024
2018 – 2022
United States locations
- U.S. sites
- 47
- U.S. states
- 21
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner Alzheimer?s Institute | Phoenix | Arizona | 85006 | — |
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | — |
| Banner Sun Health Research Insitute | Sun City | Arizona | 85351 | — |
| Health Initiatives Research, PLLC | Fayetteville | Arkansas | 72703 | — |
| Fullerton Neurology and Headache Center | Fullerton | California | 92835 | — |
| Neurology Center of North Orange County | Fullerton | California | 92835 | — |
| Irvine Center for Clinical Research | Irvine | California | 92614 | — |
| Desert Valley Research | Redlands | California | 92374 | — |
| Southern California Research LLC | Simi Valley | California | 93065 | — |
| Yale University School Of Medicine | New Haven | Connecticut | 06519 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| Accel Research Sites - CRU Tampa | Bradenton | Florida | 34201 | — |
| ClinCloud, LLC | Maitland | Florida | 32751 | — |
| Optimus U Corp | Miami | Florida | 33125 | — |
| Allied Biomedical Research Institute, Inc | Miami | Florida | 33155 | — |
| Renstar Medical Research | Ocala | Florida | 34470 | — |
| Progressive Medical Research | Port Orange | Florida | 32127 | — |
| Intercoastal Medical Group | Sarasota | Florida | 34239 | — |
| Infinity Clinical Research, LLC | Sunrise | Florida | 33351 | — |
| Axiom Clinical Research of Florida | Tampa | Florida | 33609 | — |
| Emory University | Atlanta | Georgia | 30329 | — |
| Rush Alzheimer's Disease Cntr. | Chicago | Illinois | 60612 | — |
| American Health Network Institute, LLC | Avon | Indiana | 46123 | — |
| Brigham and Womens Hospital; Center for Alzheimer Research & Treatment | Boston | Massachusetts | 02115 | — |
| ActivMed Practices and Research | Haverhill | Massachusetts | 01830 | — |
| Boston Center for Memory | Newton | Massachusetts | 02459 | — |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | — |
| Missouri Memory Center | Bolivar | Missouri | 65613 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center; Dept of Neurological Sciences | Omaha | Nebraska | 68198-8440 | — |
| Cleveland Clinic Lou Ruvo; Center for Brain Research | Las Vegas | Nevada | 89106 | — |
| The Cognitive and Research Center of New Jersey | Springfield | New Jersey | 07081 | — |
| AD-CARE, University of Rochester Medical Center | Rochester | New York | 14620 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10314 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Behavioral Health Research | Charlotte | North Carolina | 28211 | — |
| Alzheimer's Memory Center | Matthews | North Carolina | 28105 | — |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607-6520 | — |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | — |
| Neuro-Behavioral Clinical Research, Inc. | Canton | Ohio | 44718 | — |
| Cleveland Clinic; Cleveland Lou Ruvo Center for Brain Health ? Neurological Institute | Cleveland | Ohio | 44195 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Summit Research Network Inc. | Portland | Oregon | 97210 | — |
| Texas Neurology PA | Dallas | Texas | 75206 | — |
| Kerwin Medical Center | Dallas | Texas | 75231 | — |
| Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine | Houston | Texas | 77030 | — |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77054 | — |
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 108 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03443973, 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 17, 2024 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03443973 live on ClinicalTrials.gov.