Study Evaluating Bapineuzumab In Alzheimer Disease Subjects

Pfizer79 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Alzheimer Disease

Interventions

bapineuzumabDRUG

5 mg bapineuzumab subcutaneous injection once per week for 6 months

bapineuzumabDRUG

10 mg bapineuzumab subcutaneous injection once per week for 6 months

placeboDRUG

Placebo subcutaneous injection once per week for 6 months

Eligibility

Sex: ALLMin age: 50 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (17)

Pfizer Investigational Site

Phoenix, Arizona, United States

Pfizer Investigational Site

Sun City, Arizona, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline up to 30 days after Week 25 dose

Secondary Outcomes

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

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.

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 (t1/2)

Serum decay half-life is the time measured for the serum concentration to decrease by one half.

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

Time to Reach Maximum Observed Serum Concentration (Tmax)

Data from ClinicalTrials.gov

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