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NCT02051608 · ClinicalTrials.gov registry record · Phase 3
A Study of Gantenerumab in Participants With Mild Alzheimer Disease
A Phase 3 study of Alzheimers Disease, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 389
- Enrollment target
- 20
- Study locations
NCT02051608: Completed Phase 3 study of Alzheimers Disease, sponsored by Hoffmann-La Roche.
NCT02051608 is a Phase 3 study of Alzheimers Disease that has completed, run by Hoffmann-La Roche. The registered enrollment target is 389 participants, below the 3,924-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02051608, a Phase 3 study of Alzheimers Disease, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 389 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any adverse event that is fatal or
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Gantenerumab
Study Locations (20)
Florida
- Meridien Research - Brooksville
- Brain Matters Research, Inc. - Delray Beach
- Neuropsychiatric Research; Center of Southwest Florida - Fort Myers
- Miami Jewish Health Systems; Clinical Research - Miami
- Accelerated Enrollment Solutions - Orlando
- University of South Florida - Tampa
- Alzheimer's Research and Treatment Center - Wellington
California
- ATP Clinical Research, Inc - Costa Mesa
- Pacific Research Network - PRN - San Diego
- California Neuroscience Research Medical Group, Inc - Sherman Oaks
Arizona
- Banner Sun Health Research Insitute - Sun City
- Territory Neurology and Research Institute - Tucson
Louisiana
- Pennington Biomedical Research Center - Baton Rouge
- Louisiana Research Associates - New Orleans
New Jersey
- Alzheimer's Research Corporation - Paterson
- Ocean Rheumatology - Toms River
Indiana
- Indiana University - Indianapolis
Michigan
- Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research - Kalamazoo
Missouri
- Millennium Psychiatric Associates, LLC - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 389 participants |
| Start Date | 2014-03-27 |
| Est. Completion | 2021-04-16 |
| Phase | Phase 3 |
What the finished NCT02051608 record still lists
NCT02051608 is an interventional study that assigns participants to a tested intervention. The registered 389 participants enrollment target is mid-sized for trials with a published cap, below the 3,924-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02051608 names 20 study sites across 9 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT02051608 about?
NCT02051608 is a clinical study titled "A Study of Gantenerumab in Participants With Mild Alzheimer Disease". 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 subcut...
What is the current status of trial NCT02051608?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 389 participants. The study started on 2014-03-27. Estimated completion is 2021-04-16.
What conditions does trial NCT02051608 study?
This clinical trial studies the following conditions: Alzheimers Disease.
What interventions are being tested in trial NCT02051608?
The interventions under investigation include: Placebo (DRUG), Gantenerumab (DRUG).
Who is sponsoring clinical trial NCT02051608?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02051608 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimers Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02051608's enrollment target sits among peer trials
389 35th of 147 higher than 113 of 147 other Alzheimers Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimers Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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