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NCT04592341 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Pharmacodynamic (PD) Effects of Once Weekly Administration of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 2
- Development phase
- 192
- Enrollment target
NCT04592341 is a Phase 2 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 192 participants.
The verdict
NCT04592341, a Phase 2 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 192 participants
- Enrollment target
Study Summary
This is a Phase II, multicenter, open-label, single arm, PD study in participants with early (prodromal to mild) AD to evaluate the effect of a once weekly (Q1W) dosing regimen of gantenerumab on deposited amyloid as measured by change from baseline to Week 104 (primary) and Week 208 in brain amyloid positron emission tomography (PET). The administration of gantenerumab as a single injection of Q1W will be investigated in this study, to simplify the dosing regimen for participants.
Interventions
- DRUG Gantenerumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2020-11-18 |
| Est. Completion | 2023-03-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04592341
The ClinicalTrials.gov registry entry for NCT04592341 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 192 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 1 intervention - of which Gantenerumab is the first listed.
NCT04592341 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04592341 about?
NCT04592341 is a clinical study titled "A Study to Evaluate the Pharmacodynamic (PD) Effects of Once Weekly Administration of Gantenerumab in Participants With Early Alzheimer's Disease (AD)". This is a Phase II, multicenter, open-label, single arm, PD study in participants with early (prodromal to mild) AD to evaluate the effect of a once weekly (Q1W) dosing regimen of gantenerumab on deposited amyloid as measured by change from baseline to Week 104 (primary) and Week 208 in brain amyloi...
What is the current status of trial NCT04592341?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 192 participants. The study started on 2020-11-18. Estimated completion is 2023-03-15.
What interventions are being tested in trial NCT04592341?
The interventions under investigation include: Gantenerumab (DRUG).
Who is sponsoring clinical trial NCT04592341?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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