A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease
Public ClinicalTrials.gov record NCT01224106. 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
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Two Year Study to Evaluate the Effect of Subcutaneous RO4909832 on Cognition and Function in Prodromal Alzheimer's Disease With Option for up to an Additional Two Years of Treatment and an Open-Label Extension With Active Study Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This multi-center, randomized, double-blind, placebo-controlled parallel-group study will evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants will be randomized to receive subcutaneous (SC) injections of either gantenerumab or placebo. Participants who consent to be part of the sub study will undergo positron emission tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is 104 weeks in Part 1, with an option for an additional up to 2 years of treatment in Part 2, followed by an open-label extension (Part 3) until July 2020. The dosing for Parts 1 and 2 was stopped after a planned futility interim analysis showed a low probability of meeting the primary outcome measure with the doses studied. The study has converted to open-label to investigate higher gantenerumab doses.
Study identification
- NCT ID
- NCT01224106
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 799 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years to 85 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
- Nov 29, 2010
- Primary completion
- Sep 9, 2020
- Completion
- Sep 9, 2020
- Last update posted
- Dec 12, 2021
2010 – 2020
United States locations
- U.S. sites
- 24
- U.S. states
- 16
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner Alzheimer's Institute | Phoenix | Arizona | 85006 | — |
| University of California, San Diego | La Jolla | California | 92037 | — |
| Yale University ADRU | New Haven | Connecticut | 06510 | — |
| Brain Matters Research, Inc. | Delray Beach | Florida | 33445 | — |
| Infinity Clinical Research | Hollywood | Florida | 33024 | — |
| Accelerated Enrollment Solutions | Orlando | Florida | 32806 | — |
| Roskamp Institute, Inc. | Sarasota | Florida | 34243 | — |
| Compass Research | The Villages | Florida | 32162 | — |
| Premiere Research Institute | West Palm Beach | Florida | 33407 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Boston Center for Memory | Newton | Massachusetts | 02459 | — |
| Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research | Kalamazoo | Michigan | 49008 | — |
| Neurological Research Center | Hattiesburg | Mississippi | 39401 | — |
| Princeton Medical Institute | Princeton | New Jersey | 08540 | — |
| Nathan Kline Institute | Orangeburg | New York | 10962 | — |
| University of Rochester Medical Center; Monroe Community Hospital | Rochester | New York | 14627 | — |
| Alzheimer's Memory Center | Matthews | North Carolina | 28105 | — |
| Oregon Health and Science University, Layton Aging and Alzheimer's Disease Center | Portland | Oregon | 97239 | — |
| Northeastern Pennsylvania Memory | Plains | Pennsylvania | 18705 | — |
| Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | 02914 | — |
| Butler Hospital | Providence | Rhode Island | 02906 | — |
| Senior Adults Specialty Research | Austin | Texas | 78757 | — |
| Texas Neurology PA | Dallas | Texas | 75206 | — |
| Clinical Neuroscience Research Associates, Inc. | Bennington | Vermont | 05201 | — |
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 115 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01224106, 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 Dec 12, 2021 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01224106 live on ClinicalTrials.gov.