Study Evaluating Bapineuzumab In Alzheimer Disease Subjects
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Safety, Tolerability, Reactogenicity, And Pharmacokinetic Study Of Bapineuzumab (AAB 001) Administered Subcutaneously In Subjects With Mild To Moderate AD
2 other identifiers
interventional
79
1 country
17
Brief Summary
The study will evaluate the safety and effectiveness of bapineuzumab for the treatment of mild to moderate Alzheimer disease. Subjects will be in the study for six months and will receive subcutaneous injections once per week.
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 Nov 2008
17 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
First Submitted
Initial submission to the registry
April 17, 2008
CompletedFirst Posted
Study publicly available on registry
April 21, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
November 15, 2013
CompletedNovember 15, 2013
September 1, 2013
1.9 years
April 17, 2008
September 11, 2013
September 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after Week 25 dose that were absent before treatment or that worsened relative to pretreatment state.
Baseline up to 30 days after Week 25 dose
Secondary Outcomes (6)
Maximum Observed Serum Concentration (Cmax)
Predose, 4 hours [hrs] postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12
Average Serum Concentration at Steady State (Cavg,ss)
Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12
Serum Decay Half-Life (t1/2)
Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12
Time to Reach Maximum Observed Serum Concentration (Tmax)
Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12
- +1 more secondary outcomes
Study Arms (3)
A
EXPERIMENTAL5 mg/week
B
EXPERIMENTAL10 mg/week
C
EXPERIMENTALPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of probable Alzheimer Disease according to National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria
- Mini-Mental State Examination (MMSE) score 16-26
You may not qualify if:
- Magnetic Resonance Imaging (MRI) showing other brain abnormalities
- Other diagnosed neurological or psychiatric disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (17)
Pfizer Investigational Site
Phoenix, Arizona, 85006, United States
Pfizer Investigational Site
Sun City, Arizona, 85351, United States
Pfizer Investigational Site
Encino, California, 91316, United States
Pfizer Investigational Site
Los Alamitos, California, 90720, United States
Pfizer Investigational Site
Newport Beach, California, 92660, United States
Pfizer Investigational Site
Delray Beach, Florida, 33445, United States
Pfizer Investigational Site
Hallandale, Florida, 33009, United States
Pfizer Investigational Site
West Palm Beach, Florida, 33407, United States
Pfizer Investigational Site
Decatur, Georgia, 30033, United States
Pfizer Investigational Site
Lawrenceville, Georgia, 30045, United States
Pfizer Investigational Site
Wichita, Kansas, 67211, United States
Pfizer Investigational Site
Rochester, New York, 14620, United States
Pfizer Investigational Site
East Providence, Rhode Island, 02914, United States
Pfizer Investigational Site
Providence, Rhode Island, 02906, United States
Pfizer Investigational Site
Dallas, Texas, 75214, United States
Pfizer Investigational Site
Bennington, Vermont, 05201, United States
Pfizer Investigational Site
Madison, Wisconsin, 53705, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Designation of outcomes as primary, secondary was based on study team's input as study did not specify them as primary or secondary.
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
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2008
First Posted
April 21, 2008
Study Start
November 1, 2008
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
November 15, 2013
Results First Posted
November 15, 2013
Record last verified: 2013-09