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NCT03444870 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,053
- Enrollment target
NCT03444870: Clinical Trial Phase 3 study, sponsored by Hoffmann-La Roche.
NCT03444870 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 1,053 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03444870, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,053 participants
- Enrollment target
Study Summary
This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 116. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.
Primary Outcome
CDR was derived through semi-structured interview with the participant and an appropriate informant, and it rated impairment across six domains: memory, orientation, judgment, and problem solving, community affairs, home and hobbies, and personal care on a 5-point scale for which 0=no impairment, 0.5=questionable impairment, and 1, 2, and 3=mild, moderate, and severe impairment, respectively. The CDR-SB is based on summing each of the domain box scores with total score ranging from 0-18 with hig
Interventions
- DRUG Placebo
- DRUG Gantenerumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,053 participants |
| Start Date | 2018-06-06 |
| Est. Completion | 2023-02-17 |
| Phase | Phase 3 |
Why NCT03444870 stopped before completion
NCT03444870 is an interventional study that assigns participants to a tested intervention. Its 1,053 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 (36% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03444870 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03444870 about?
NCT03444870 is a clinical study titled "Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)". This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 ...
What is the current status of trial NCT03444870?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,053 participants. The study started on 2018-06-06. Estimated completion is 2023-02-17.
What interventions are being tested in trial NCT03444870?
The interventions under investigation include: Placebo (DRUG), Gantenerumab (DRUG).
Who is sponsoring clinical trial NCT03444870?
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 NCT03444870's enrollment target sits among peer trials
1,053 278th of 2000 higher than 1,723 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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