A Study of Gantenerumab in Participants With Mild Alzheimer Disease
Public ClinicalTrials.gov record NCT02051608. 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, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Gantenerumab in Patients With Mild Alzheimer's Disease; Part II: Open-Label Extension For Participating Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer disease. Participants will be randomized to receive either gantenerumab subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE). A positron emission tomography (PET) imaging substudy will be conducted within the main study. Eligible participants who provide separate informed consent will undergo PET imaging scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain amyloid load over time.
Study identification
- NCT ID
- NCT02051608
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 389 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
- Mar 27, 2014 (Actual)
- Primary completion
- Apr 16, 2021 (Actual)
- Completion
- Apr 16, 2021 (Actual)
- Last update posted
- Feb 10, 2023
2014 – 2021
United States locations
- U.S. sites
- 30
- U.S. states
- 16
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner Sun Health Research Insitute | Sun City | Arizona | 85351 | — |
| Territory Neurology and Research Institute | Tucson | Arizona | 85704 | — |
| ATP Clinical Research, Inc | Costa Mesa | California | 92626 | — |
| Pacific Research Network - PRN | San Diego | California | 92103 | — |
| California Neuroscience Research Medical Group, Inc | Sherman Oaks | California | 91403 | — |
| Meridien Research | Brooksville | Florida | 34601 | — |
| Brain Matters Research, Inc. | Delray Beach | Florida | 33445 | — |
| Neuropsychiatric Research; Center of Southwest Florida | Fort Myers | Florida | 33912 | — |
| Miami Jewish Health Systems; Clinical Research | Miami | Florida | 33137 | — |
| Accelerated Enrollment Solutions | Orlando | Florida | 32806 | — |
| University of South Florida | Tampa | Florida | 33613-4706 | — |
| Alzheimer's Research and Treatment Center | Wellington | Florida | 33414 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | — |
| Louisiana Research Associates | New Orleans | Louisiana | 70114 | — |
| Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research | Kalamazoo | Michigan | 49008 | — |
| Millennium Psychiatric Associates, LLC | St Louis | Missouri | 63132 | — |
| Alzheimer's Research Corporation | Paterson | New Jersey | 08759 | — |
| Ocean Rheumatology | Toms River | New Jersey | 08775 | — |
| Nathan Kline Institute | Orangeburg | New York | 10962 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | — |
| Alzheimer's Memory Center | Matthews | North Carolina | 28105 | — |
| Richard H Weisler, MD | Raleigh | North Carolina | 27609 | — |
| Central States Research | Tulsa | Oklahoma | 74136 | — |
| Abington Neurological Associates | Abington | Pennsylvania | 19001 | — |
| Northeastern Pennsylvania Memory | Plains | Pennsylvania | 18705 | — |
| Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | 02914 | — |
| Neurology Clinic PC | Cordova | Tennessee | 38018 | — |
| Senior Adults Specialty Research | Austin | Texas | 78757 | — |
| University of Utah, Center for Alzheimer's Care Imaging & Research | Salt Lake City | Utah | 84108 | — |
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 101 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02051608, 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 Feb 10, 2023 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02051608 live on ClinicalTrials.gov.