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

This study has been terminated.
(The study was terminated on August 6, 2012, because 2 large Phase 3 studies showed no clinical benefit. This decision was not based on any new safety concerns.)
Sponsor:
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00916617
First received: June 4, 2009
Last updated: November 28, 2012
Last verified: November 2012

June 4, 2009
November 28, 2012
June 2009
September 2012   (final data collection date for primary outcome measure)
Safety endpoints, including brain MRI [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Safety endpoints, including brain MRI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00916617 on ClinicalTrials.gov Archive Site
Pharmacokinetic parameters including maximal serum drug concentration, time to maximal serum drug concentration, and terminal half-life of elimination [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Pharmacokinetic parameters including maximal serum drug concentration, time to maximal serum drug concentration, and terminal half-life of elimination [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab
A Multicenter, Open-Label, Multiple Dose, Parallel Group Investigation Of The Long-Term Safety, Tolerability, Reactogenicity And Efficacy Of Bapineuzumab Administered Subcutaneously In Subjects With Mild To Moderate Alzheimer Disease

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer Disease
Drug: bapineuzumab
5 mg/week subcutaneous bapineuzumab
Experimental: 1
5 mg/week
Intervention: Drug: bapineuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
66
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of probable Alzheimer disease
  • Completed preceding double-blind study (3133L1-2203 US)
  • MMSE score > 9.

Exclusion Criteria:

  • Significant brain MRI abnormalities
  • Clinically important psychiatric symptoms
  • History of stroke
Both
50 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00916617
3133L1-2204, B2521009
Yes
Pfizer
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP