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Study Evaluating Bapineuzumab In Alzheimer Disease Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00663026
Recruitment Status : Completed
First Posted : April 21, 2008
Results First Posted : November 15, 2013
Last Update Posted : November 15, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: bapineuzumab Drug: placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: A
5 mg/week
 Drug: bapineuzumab
5 mg bapineuzumab subcutaneous injection once per week for 6 months
Experimental: B
10 mg/week
 Drug: bapineuzumab
10 mg bapineuzumab subcutaneous injection once per week for 6 months
Experimental: C
Placebo
 Drug: placebo
Placebo subcutaneous injection once per week for 6 months


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 30 days after Week 25 dose ]
    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.


Secondary Outcome Measures :
  1. Maximum Observed Serum Concentration (Cmax) [ Time Frame: 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 ]
  2. Average Serum Concentration at Steady State (Cavg,ss) [ Time Frame: 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 ]
    Average plasma concentration at steady state (Cavg,ss) = AUCtau divided by dosing interval (1 week). AUCtau is the area under the plasma concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 1 week.

  3. Serum Decay Half-Life (t1/2) [ Time Frame: 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 is the time measured for the serum concentration to decrease by one half.

  4. Time to Reach Maximum Observed Serum Concentration (Tmax) [ Time Frame: 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 ]
  5. Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) [ Time Frame: 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 ]
    AUCtau is the area under the serum concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 1 week.

  6. Apparent Systemic Clearance (CL/F) [ Time Frame: 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 ]
    Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction (F) of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Steady-state apparent systemic clearance (CL/F) was calculated as dose/AUC tau.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Magnetic Resonance Imaging (MRI) showing other brain abnormalities
  • Other diagnosed neurological or psychiatric disorders
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663026


Locations
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United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85006
Pfizer Investigational Site
Sun City, Arizona, United States, 85351
United States, California
Pfizer Investigational Site
Encino, California, United States, 91316
Pfizer Investigational Site
Los Alamitos, California, United States, 90720
Pfizer Investigational Site
Newport Beach, California, United States, 92660
United States, Florida
Pfizer Investigational Site
Delray Beach, Florida, United States, 33445
Pfizer Investigational Site
Hallandale, Florida, United States, 33009
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Georgia
Pfizer Investigational Site
Decatur, Georgia, United States, 30033
Pfizer Investigational Site
Lawrenceville, Georgia, United States, 30045
United States, Kansas
Pfizer Investigational Site
Wichita, Kansas, United States, 67211
United States, New York
Pfizer Investigational Site
Rochester, New York, United States, 14620
United States, Rhode Island
Pfizer Investigational Site
East Providence, Rhode Island, United States, 02914
Pfizer Investigational Site
Providence, Rhode Island, United States, 02906
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75214
United States, Vermont
Pfizer Investigational Site
Bennington, Vermont, United States, 05201
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00663026    
Other Study ID Numbers: 3133L1-2203
B2521008
First Posted: April 21, 2008    Key Record Dates
Results First Posted: November 15, 2013
Last Update Posted: November 15, 2013
Last Verified: September 2013
Keywords provided by Pfizer:
antibody
immunotherapy
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders