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

NCT ID: NCT00916617

Last Updated: 2017-06-01

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-09-30

Brief Summary

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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

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

5 mg/week

Group Type EXPERIMENTAL

bapineuzumab

Intervention Type DRUG

5 mg/week subcutaneous bapineuzumab

Interventions

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bapineuzumab

5 mg/week subcutaneous bapineuzumab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JANSSEN Alzheimer Immunotherapy Research & Development, LLC

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Banner Alzheimer's Institute

Phoenix, Arizona, United States

Site Status

Pharmacology Research Institute

Encino, California, United States

Site Status

Brain Matters Research

Delray Beach, Florida, United States

Site Status

MD Clinical

Hallandale, Florida, United States

Site Status

Palm Beach Neurology - Premiere Research Institute

West Palm Beach, Florida, United States

Site Status

Neurostudies.net

Decatur, Georgia, United States

Site Status

Dekalb Neurology Associates, LLC

Lawrenceville, Georgia, United States

Site Status

NeuroStudies.net

Lawrenceville, Georgia, United States

Site Status

Clinical Research Institute

Wichita, Kansas, United States

Site Status

Monroe Community Hospital

Rochester, New York, United States

Site Status

Rhode Island Mood and Memory Research Institute

East Providence, Rhode Island, United States

Site Status

Butler Hospital

Providence, Rhode Island, United States

Site Status

Texas Neurology, P.A.

Dallas, Texas, United States

Site Status

The Memory Clinic

Bennington, Vermont, United States

Site Status

University of Wisconsin, Department of Surgery

Madison, Wisconsin, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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B2521009

Identifier Type: OTHER

Identifier Source: secondary_id

3133L1-2204

Identifier Type: -

Identifier Source: org_study_id

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