Study Stopped
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.
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, Pharmacokinetics And Pharmacodynamics Of Aab-001 Administered Subcutaneously In Subjects With Mild To Moderate Alzheimer's Disease
2 other identifiers
interventional
62
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 alzheimer-disease
Started Jun 2009
Typical duration for phase_2 alzheimer-disease
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 4, 2009
CompletedFirst Posted
Study publicly available on registry
June 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
June 1, 2017
CompletedJune 1, 2017
April 1, 2017
3.3 years
June 4, 2009
September 25, 2013
April 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings
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 Outcomes (1)
Pharmacokinetic Parameters Including Maximal Serum Drug Concentration, Time to Maximal Serum Drug Concentration, and Terminal Half-life of Elimination
36 months
Study Arms (1)
1
EXPERIMENTAL5 mg/week
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of probable Alzheimer disease
- Completed preceding double-blind study (3133L1-2203 US)
- MMSE score \> 9.
You may not qualify if:
- Significant brain MRI abnormalities
- Clinically important psychiatric symptoms
- History of stroke
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Pharmacology Research Institute
Encino, California, 91316, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
MD Clinical
Hallandale, Florida, 33009, United States
Palm Beach Neurology - Premiere Research Institute
West Palm Beach, Florida, 33407, United States
Neurostudies.net
Decatur, Georgia, 30033, United States
Dekalb Neurology Associates, LLC
Lawrenceville, Georgia, 30045, United States
NeuroStudies.net
Lawrenceville, Georgia, 30046, United States
Clinical Research Institute
Wichita, Kansas, 67207, United States
Monroe Community Hospital
Rochester, New York, 14620, United States
Rhode Island Mood and Memory Research Institute
East Providence, Rhode Island, 02914, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
Texas Neurology, P.A.
Dallas, Texas, 75214, United States
The Memory Clinic
Bennington, Vermont, 05201, United States
University of Wisconsin, Department of Surgery
Madison, Wisconsin, 53705, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2009
First Posted
June 9, 2009
Study Start
June 1, 2009
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
June 1, 2017
Results First Posted
June 1, 2017
Record last verified: 2017-04