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NCT03289143 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of Semorinemab in Patients With Prodromal to Mild Alzheimer's Disease
A Phase 2 study, sponsored by Genentech.
- Terminated
- Registry status
- Phase 2
- Development phase
- 457
- Enrollment target
NCT03289143: Clinical Trial Phase 2 study, sponsored by Genentech.
NCT03289143 is a Phase 2 study that was terminated before completion, run by Genentech. The registered enrollment target is 457 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (244% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03289143, a Phase 2 study, was terminated before completion, sponsored by Genentech.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 457 participants
- Enrollment target
Study Summary
This was a phase II, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of Semorinemab in participants with prodromal to mild Alzheimer's disease. An optional 96-week open-label extension period was available to participants who completed the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label Semorinemab treatment.
Primary Outcome
The Clinical Dementia Rating-Sum of Boxes (CDR-SB) rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment = 0, questionable impairment = 0.5 and mild, moderate and severe impairment = 1, 2 and 3 respectively. The score range is from 0 to 18 with a high score indicating a high disease severity. The difference in mean change from Baseline to Week 73 between Semorinemab do
Interventions
- DRUG Placebo
- DRUG [18F]GTP1
- DRUG Semorinemab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 457 participants |
| Start Date | 2017-10-04 |
| Est. Completion | 2021-01-15 |
| Phase | Phase 2 |
Why NCT03289143 stopped before completion
NCT03289143 is an interventional study that assigns participants to a tested intervention. The registered 457 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (244% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03289143 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03289143 about?
NCT03289143 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Semorinemab in Patients With Prodromal to Mild Alzheimer's Disease". This was a phase II, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of Semorinemab in participants with prodromal to mild Alzheimer's disease. An optional 96-week open-label extension period was available to participants who completed the double-blind treatmen...
What is the current status of trial NCT03289143?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 457 participants. The study started on 2017-10-04. Estimated completion is 2021-01-15.
What interventions are being tested in trial NCT03289143?
The interventions under investigation include: Placebo (DRUG), [18F]GTP1 (DRUG), Semorinemab (DRUG).
Who is sponsoring clinical trial NCT03289143?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03289143's enrollment target sits among peer trials
457 84th of 2000 higher than 1,917 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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