Study Evaluating Bapineuzumab In Alzheimer Disease Subjects

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

bapineuzumab

placebo

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring antibody, immunotherapy

Eligibility Criteria

50 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

A

B

C

Arm Description

5 mg/week

10 mg/week

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Maximum Observed Serum Concentration (Cmax)

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.

Serum Decay Half-Life (t1/2)

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)

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.

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.

Full Information

NCT ID

NCT00663026

First Posted

April 17, 2008

Last Updated

September 11, 2013

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00663026

Brief Title

Study Evaluating Bapineuzumab In Alzheimer Disease Subjects

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 Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

Keywords

antibody, immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A

Arm Type

Experimental

Arm Description

5 mg/week

Arm Title

B

Arm Type

Experimental

Arm Description

10 mg/week

Arm Title

C

Arm Type

Experimental

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

bapineuzumab

Intervention Description

5 mg bapineuzumab subcutaneous injection once per week for 6 months

Intervention Type

Drug

Intervention Name(s)

bapineuzumab

Intervention Description

10 mg bapineuzumab subcutaneous injection once per week for 6 months

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo subcutaneous injection once per week for 6 months

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Baseline up to 30 days after Week 25 dose

Secondary Outcome Measure Information:

Title

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

Title

Average Serum Concentration at Steady State (Cavg,ss)

Description

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.

Time Frame