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NCT04374253 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,382
- Enrollment target
NCT04374253: Clinical Trial Phase 3 study, sponsored by Hoffmann-La Roche.
NCT04374253 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 1,382 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04374253, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,382 participants
- Enrollment target
Study Summary
This is an open-label, multicenter, rollover study to evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with AD who completed Study WN29922 or WN39658, either the double-blind or open-label extension (OLE) part.
Primary Outcome
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of casual attribution. A SAE is any AE that is fatal, life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug or a significant medical event in the investigator's judgment. The first dosing visit in the
Interventions
- DRUG Gantenerumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,382 participants |
| Start Date | 2021-01-26 |
| Est. Completion | 2023-03-06 |
| Phase | Phase 3 |
Why NCT04374253 stopped before completion
NCT04374253 is an interventional study that assigns participants to a tested intervention. Its 1,382 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% higher).
The record links to 0 conditions, and to 1 intervention - of which Gantenerumab is the first listed.
NCT04374253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04374253 about?
NCT04374253 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)". This is an open-label, multicenter, rollover study to evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with AD who completed Study WN29922 or WN39658, either the double-blind or open-label extension (OLE) part.
What is the current status of trial NCT04374253?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,382 participants. The study started on 2021-01-26. Estimated completion is 2023-03-06.
What interventions are being tested in trial NCT04374253?
The interventions under investigation include: Gantenerumab (DRUG).
Who is sponsoring clinical trial NCT04374253?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04374253's enrollment target sits among peer trials
1,382 176th of 2000 higher than 1,825 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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