Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab

Phase 2TerminatedNCT00916617

Pfizer62 enrolled

Overview

This study will evaluate the safety and tolerability of bapineuzumab when administered by subcutaneous injection. The study is open only to subjects who participated in the preceding double-blind study (3133L1-2203 US). Subjects will receive weekly injections of bapineuzumab for 3 years (156 doses). One dosage level will be included: 5 mg/week. All subjects will receive active treatment (bapineuzumab) and no subjects will receive placebo.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alzheimer Disease

Interventions

bapineuzumabDRUG

5 mg/week subcutaneous bapineuzumab

Eligibility

Sex: ALLMin age: 50 YearsMax age: 89 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of probable Alzheimer disease * Completed preceding double-blind study (3133L1-2203 US) * MMSE score \> 9. Exclusion Criteria: * Significant brain MRI abnormalities * Clinically important psychiatric symptoms * History of stroke

Locations (16)

Banner Alzheimer's Institute

Phoenix, Arizona, United States

Pharmacology Research Institute

Encino, California, United States

Outcomes

Primary Outcomes

Number of Participants Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings

A brain Magnetic Resonance Imaging (MRI) was obtained from all participants at Week 13 and quarterly thereafter. Participants were to meet the following criteria: screening brain MRI scan is consistent with the diagnosis of Alzheimer's Disease. Screening diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria. Clinically significant MRIs were identified by the investigator. The number of participants with clinically significant MRIs are tabulated by visit and treatment group.

Time frame: Week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, Any visit

Secondary Outcomes

Pharmacokinetic Parameters Including Maximal Serum Drug Concentration, Time to Maximal Serum Drug Concentration, and Terminal Half-life of Elimination

Time frame: 36 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.