Clinical trial NCT00663026: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: antibody
immunotherapy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-21
Enrollment: 79
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 30 days after Week 25 dose
Secondary outcomes:
measure: Maximum Observed Serum Concentration (Cmax)
timeFrame: 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
measure: Average Serum Concentration at Steady State (Cavg,ss)
timeFrame: 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
measure: Serum Decay Half-Life (t1/2)
timeFrame: 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
measure: Time to Reach Maximum Observed Serum Concentration (Tmax)
timeFrame: 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
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
timeFrame: 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
measure: Apparent Systemic Clearance (CL/F)
timeFrame: 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
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Sun City
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Encino
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Alamitos
country: United States
facility: Pfizer Investigational Site
state: California
city: Newport Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Delray Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hallandale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Lawrenceville
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: East Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Bennington
country: United States
facility: Pfizer Investigational Site
state: Vermont
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: