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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00916617
• Other study ID #: 3133L1-2204
• Secondary ID: B2521009
• Status: Terminated
• Phase: Phase 2
• First received: June 4, 2009
• Last updated: November 28, 2012
• Start date: June 2009
• Est. completion date: September 2012

Study information

• Verified date: November 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• bapineuzumab
5 mg/week subcutaneous bapineuzumab

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Bennington	Vermont
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Delray Beach	Florida
United States	Pfizer Investigational Site	East Providence	Rhode Island
United States	Pfizer Investigational Site	Encino	California
United States	Pfizer Investigational Site	Hallandale Beach	Florida
United States	Pfizer Investigational Site	Lawrenceville	Georgia
United States	Pfizer Investigational Site	Lawrenceville	Georgia
United States	Pfizer Investigational Site	Los Alamitos	California
United States	Pfizer Investigational Site	Madison	Wisconsin
United States	Pfizer Investigational Site	Maidson	Wisconsin
United States	Pfizer Investigational Site	Newport Beach	California
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Providence	Rhode Island
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	West Palm Beach	Florida
United States	Pfizer Investigational Site	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety endpoints, including brain MRI		36 months	Yes
Secondary	Pharmacokinetic parameters including maximal serum drug concentration, time to maximal serum drug concentration, and terminal half-life of elimination		36 months	No

External Links

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