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

Phase 2

Terminated

• Conditions: Alzheimer Disease
• Interventions: Drug: bapineuzumab

• Registration Number: NCT00916617
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-04
• Study First Submitted QC: 2009-06-05
• Study First Posted: 2009-06-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Results First Submitted: 2013-09-25
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-27
• Last Update Submitted: 2017-04-27
• Results First Posted: 2017-06-01
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	bapineuzumab	5 mg/week

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings	Week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, Any visit	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.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic Parameters Including Maximal Serum Drug Concentration, Time to Maximal Serum Drug Concentration, and Terminal Half-life of Elimination	36 months

Trial Locations

Locations (16)

Banner Alzheimer's Institute; 🇺🇸 Phoenix, Arizona, United States

Pharmacology Research Institute; 🇺🇸 Encino, California, United States

Brain Matters Research; 🇺🇸 Delray Beach, Florida, United States

MD Clinical; 🇺🇸 Hallandale Beach, Florida, United States

Palm Beach Neurology - Premiere Research Institute; 🇺🇸 West Palm Beach, Florida, United States

Neurostudies.net; 🇺🇸 Decatur, Georgia, United States

Dekalb Neurology Associates, LLC; 🇺🇸 Lawrenceville, Georgia, United States

NeuroStudies.net; 🇺🇸 Lawrenceville, Georgia, United States

Clinical Research Institute; 🇺🇸 Wichita, Kansas, United States

Monroe Community Hospital; 🇺🇸 Rochester, New York, United States

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