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NCT00916617 · ClinicalTrials.gov registry record · Phase 2

Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab

A Phase 2 study, sponsored by Pfizer.

Terminated
Registry status
Phase 2
Development phase
62
Enrollment target

NCT00916617: Clinical Trial Phase 2 study, sponsored by Pfizer.

NCT00916617 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00916617, a Phase 2 study, was terminated before completion, sponsored by Pfizer.

TERMINATED
Registry status
Phase 2
Development phase
62 participants
Enrollment target

Study Summary

This study will evaluate the safety and tolerability of bapineuzumab when administered by subcutaneous injection. The study is open only to subjects who participated in the preceding double-blind study (3133L1-2203 US). Subjects will receive weekly injections of bapineuzumab for 3 years (156 doses). One dosage level will be included: 5 mg/week. All subjects will receive active treatment (bapineuzumab) and no subjects will receive placebo.

Primary Outcome

A brain Magnetic Resonance Imaging (MRI) was obtained from all participants at Week 13 and quarterly thereafter. Participants were to meet the following criteria: screening brain MRI scan is consistent with the diagnosis of Alzheimer's Disease. Screening diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria. Clinically significant MRIs were iden

Interventions

  • DRUG bapineuzumab

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2009-06
Est. Completion 2012-09
Phase Phase 2
Pfizer

1,845 total trials

Why NCT00916617 stopped before completion

NCT00916617 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 1 intervention - of which bapineuzumab is the first listed.

NCT00916617 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00916617 about?

NCT00916617 is a clinical study titled "Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab". This study will evaluate the safety and tolerability of bapineuzumab when administered by subcutaneous injection. The study is open only to subjects who participated in the preceding double-blind study (3133L1-2203 US). Subjects will receive weekly injections of bapineuzumab for 3 years (156 doses)....

What is the current status of trial NCT00916617?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2009-06. Estimated completion is 2012-09.

What interventions are being tested in trial NCT00916617?

The interventions under investigation include: bapineuzumab (DRUG).

Who is sponsoring clinical trial NCT00916617?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00916617's enrollment target sits among peer trials

62 1016th of 2000 higher than 975 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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Source: ClinicalTrials.gov NCT00916617, the US trial registry maintained by the National Library of Medicine. NCT00916617 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.