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NCT00606476 · ClinicalTrials.gov registry record · Phase 2
AAB-001 (Bapineuzumab) Open-Label, Long-Term Extension Study in Patients With Mild to Moderate Alzheimer's Disease
A Phase 2 study, sponsored by JANSSEN Alzheimer Immunotherapy Research & Development.
- Terminated
- Registry status
- Phase 2
- Development phase
- 194
- Enrollment target
NCT00606476: Clinical Trial Phase 2 study, sponsored by JANSSEN Alzheimer Immunotherapy Research & Development.
NCT00606476 is a Phase 2 study that was terminated before completion, run by JANSSEN Alzheimer Immunotherapy Research & Development. The registered enrollment target is 194 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00606476, a Phase 2 study, was terminated before completion, sponsored by JANSSEN Alzheimer Immunotherapy Research & Development.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 194 participants
- Enrollment target
Study Summary
This is a multicenter, open-label, long-term extension study in male and female patients with mild to moderate Alzheimer's Disease (AD) who must have completed one of the following studies: AAB-001-201 or AAB-001-102. All patients enrolled in Study AAB-001-251 will receive infusions of AAB-001 (bapineuzumab), including patients randomized to placebo in Study 201 and 102. Approximately 30 study sites in the US will be involved. Each patient's participation may vary from 3 months up to 84 months depending on the date of enrollment in this study. AAB-001 (bapineuzumab) is a humanized monoclonal antibody, which binds to and potentially clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.
Primary Outcome
* The incidence and severity of treatment-emergent adverse events (TEAEs); * Clinically important changes in safety assessment results (including, as appropriate, vital signs, weight, clinical laboratory tests, electrocardiograms \[ECGs\], brain magnetic resonance imaging \[MRIs\], physical and neurological examinations, and infusion site assessments).
Interventions
- DRUG Bapineuzumab (AAB-001)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2006-12 |
| Est. Completion | 2012-09 |
| Phase | Phase 2 |
Why NCT00606476 stopped before completion
NCT00606476 is an interventional study that assigns participants to a tested intervention. The registered 194 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 (46% higher).
The record links to 0 conditions, and to 1 intervention - of which Bapineuzumab (AAB-001) is the first listed.
NCT00606476 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00606476 about?
NCT00606476 is a clinical study titled "AAB-001 (Bapineuzumab) Open-Label, Long-Term Extension Study in Patients With Mild to Moderate Alzheimer's Disease". This is a multicenter, open-label, long-term extension study in male and female patients with mild to moderate Alzheimer's Disease (AD) who must have completed one of the following studies: AAB-001-201 or AAB-001-102. All patients enrolled in Study AAB-001-251 will receive infusions of AAB-001 (bapi...
What is the current status of trial NCT00606476?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 194 participants. The study started on 2006-12. Estimated completion is 2012-09.
What interventions are being tested in trial NCT00606476?
The interventions under investigation include: Bapineuzumab (AAB-001) (DRUG).
Who is sponsoring clinical trial NCT00606476?
This trial is sponsored by JANSSEN Alzheimer Immunotherapy Research & Development, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00606476's enrollment target sits among peer trials
194 352nd of 2000 higher than 1,649 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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