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

April 27, 2017 updated by: Pfizer

A Multicenter, Open Label, Multiple Dose, Parallel Group Investigation Of The Long-term Safety, Tolerability, Reactogenicity, Pharmacokinetics And Pharmacodynamics Of Aab-001 Administered Subcutaneously In Subjects With Mild To Moderate Alzheimer's 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner Alzheimer's Institute
    • California
      • Encino, California, United States, 91316
        • Pharmacology Research Institute
    • Florida
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research
      • Hallandale Beach, Florida, United States, 33009
        • MD Clinical
      • West Palm Beach, Florida, United States, 33407
        • Palm Beach Neurology - Premiere Research Institute
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Neurostudies.net
      • Lawrenceville, Georgia, United States, 30045
        • Dekalb Neurology Associates, LLC
      • Lawrenceville, Georgia, United States, 30046
        • Neurostudies.net
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Clinical Research Institute
    • New York
      • Rochester, New York, United States, 14620
        • Monroe Community Hospital
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Rhode Island mood and memory research institute
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital
    • Texas
      • Dallas, Texas, United States, 75214
        • Texas Neurology, P.A.
    • Vermont
      • Bennington, Vermont, United States, 05201
        • The Memory Clinic
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin, Department of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
5 mg/week
Drug: bapineuzumab
5 mg/week subcutaneous bapineuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings
Time Frame: Week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, Any visit
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 identified by the investigator. The number of participants with clinically significant MRIs are tabulated by visit and treatment group.
Week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, Any visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic Parameters Including Maximal Serum Drug Concentration, Time to Maximal Serum Drug Concentration, and Terminal Half-life of Elimination
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

June 4, 2009

First Submitted That Met QC Criteria

June 5, 2009

First Posted (Estimate)

June 9, 2009

Study Record Updates

Last Update Posted (Actual)

June 1, 2017

Last Update Submitted That Met QC Criteria

April 27, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3133L1-2204
  • B2521009 (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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