Study Evaluating Bapineuzumab In Alzheimer Disease Subjects

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663026
• Other study ID #: 3133L1-2203
• Secondary ID: B2521008
• Status: Completed
• Phase: Phase 2
• First received: April 17, 2008
• Last updated: September 11, 2013
• Start date: November 2008
• Est. completion date: October 2010

Study information

• Verified date: September 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 89 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• bapineuzumab
5 mg bapineuzumab subcutaneous injection once per week for 6 months
• bapineuzumab
10 mg bapineuzumab subcutaneous injection once per week for 6 months
• placebo
Placebo subcutaneous injection once per week for 6 months

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Bennington	Vermont
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Delray Beach	Florida
United States	Pfizer Investigational Site	East Providence	Rhode Island
United States	Pfizer Investigational Site	Encino	California
United States	Pfizer Investigational Site	Hallandale	Florida
United States	Pfizer Investigational Site	Lawrenceville	Georgia
United States	Pfizer Investigational Site	Los Alamitos	California
United States	Pfizer Investigational Site	Madison	Wisconsin
United States	Pfizer Investigational Site	Newport Beach	California
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Providence	Rhode Island
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	Sun City	Arizona
United States	Pfizer Investigational Site	West Palm Beach	Florida
United States	Pfizer Investigational Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	Average Serum Concentration at Steady State (Cavg,ss)	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.	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	No
Secondary	Serum Decay Half-Life (t1/2)	Serum decay half-life is the time measured for the serum concentration to decrease by one half.	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	No
Secondary	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	No
Secondary	Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)	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.	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	No
Secondary	Apparent Systemic Clearance (CL/F)	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.	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	No

External Links

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