Study Evaluating Bapineuzumab In Alzheimer Disease Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00663026
First received: April 17, 2008
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Alzheimer Disease
Drug: bapineuzumab
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    Serum decay half-life is the time measured for the serum concentration to decrease by one half.

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 79
Study Start Date: November 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 89 Years
Genders Eligible for Study:   Both
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
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: NCT00663026

Locations
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
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00663026     History of Changes
Other Study ID Numbers: 3133L1-2203, B2521008
Study First Received: April 17, 2008
Results First Received: September 11, 2013
Last Updated: September 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
antibody
immunotherapy

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014