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NCT01224106 · ClinicalTrials.gov registry record · Phase 3
A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 799
- Enrollment target
NCT01224106 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 799 participants.
The verdict
NCT01224106, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 799 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG Gantenerumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 799 participants |
| Start Date | 2010-11-30 |
| Est. Completion | 2020-09-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01224106
The ClinicalTrials.gov registry entry for NCT01224106 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 799 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01224106 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01224106 about?
NCT01224106 is a clinical study titled "A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease". 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 su...
What is the current status of trial NCT01224106?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 799 participants. The study started on 2010-11-30. Estimated completion is 2020-09-10.
What interventions are being tested in trial NCT01224106?
The interventions under investigation include: Placebo (DRUG), Gantenerumab (DRUG).
Who is sponsoring clinical trial NCT01224106?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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