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A Long-Term Safety And Tolerability Study Of Bapineuzumab In Alzheimer Disease Patients

NCT00996918 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2014-01-01

Study results available
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Summary

The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab in subjects with Alzheimer Disease who participated in study 3133K1-3000 (NCT00667810). Over 250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each subject's participation will last approximately 4 years.

Conditions

  • Alzheimer Disease

Interventions

DRUG

Bapineuzumab 0.5 mg/kg

Bapineuzumab I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.

DRUG

Bapineuzumab 1.0 m/kg

I.V., 1.0 mg/kg, infusion every 13 weeks for a total of 16 infusions.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
51 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Australia
  • Belgium
  • Chile
  • Finland
  • France
  • Italy
  • Japan
  • Netherlands
  • New Zealand
  • Poland
  • Portugal
  • Slovakia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00996918 on ClinicalTrials.gov