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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: April 27, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Alzheimer Disease Drug: bapineuzumab Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Pharmacokinetic Parameters Including Maximal Serum Drug Concentration, Time to Maximal Serum Drug Concentration, and Terminal Half-life of Elimination [ Time Frame: 36 months ]

Enrollment: 62
Study Start Date: June 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
5 mg/week
Drug: bapineuzumab
5 mg/week subcutaneous bapineuzumab

  Eligibility

Ages Eligible for Study:   50 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916617

Locations
United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
United States, California
Pharmacology Research Institute
Encino, California, United States, 91316
United States, Florida
Brain Matters Research
Delray Beach, Florida, United States, 33445
MD Clinical
Hallandale Beach, Florida, United States, 33009
Palm Beach Neurology - Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Georgia
Neurostudies.net
Decatur, Georgia, United States, 30033
Dekalb Neurology Associates, LLC
Lawrenceville, Georgia, United States, 30045
NeuroStudies.net
Lawrenceville, Georgia, United States, 30046
United States, Kansas
Clinical Research Institute
Wichita, Kansas, United States, 67207
United States, New York
Monroe Community Hospital
Rochester, New York, United States, 14620
United States, Rhode Island
Rhode Island Mood and Memory Research Institute
East Providence, Rhode Island, United States, 02914
Butler Hospital
Providence, Rhode Island, United States, 02906
United States, Texas
Texas Neurology, P.A.
Dallas, Texas, United States, 75214
United States, Vermont
The Memory Clinic
Bennington, Vermont, United States, 05201
United States, Wisconsin
University of Wisconsin, Department of Surgery
Madison, Wisconsin, United States, 53705
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00916617     History of Changes
Other Study ID Numbers: 3133L1-2204
B2521009 ( Other Identifier: Alias Study Number )
Study First Received: June 4, 2009
Results First Received: September 25, 2013
Last Updated: April 27, 2017

Keywords provided by Pfizer:
open-label
safety
antibody

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 28, 2017