Study Evaluating Bapineuzumab In Alzheimer Disease Subjects

Phase 2

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: bapineuzumab; Drug: placebo

• Registration Number: NCT00663026
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-17
• Study First Submitted QC: 2008-04-19
• Study First Posted: 2008-04-21
• Study Start: 2008-11
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Disposition First Submitted: 2012-03-27
• Disposition First Submitted QC: 2012-03-27
• Disposition First Posted: 2012-03-30
• Status Verified: 2013-09
• Results First Submitted: 2013-09-11
• Results First Submitted QC: 2013-09-11
• Last Update Submitted: 2013-09-11
• Results First Posted: 2013-11-15
• Last Update Posted: 2013-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

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Exclusion Criteria

• Magnetic Resonance Imaging (MRI) showing other brain abnormalities
• Other diagnosed neurological or psychiatric disorders

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	bapineuzumab	5 mg/week
B	bapineuzumab	10 mg/week
C	placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	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

Name	Time	Method
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	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)	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.
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	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)	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Madison, Wisconsin, United States