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Study Evaluating Bapineuzumab In Alzheimer Disease Subjects

NCT ID: NCT00663026

Last Updated: 2013-11-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease

Keywords

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antibody immunotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

5 mg/week

Group Type EXPERIMENTAL

bapineuzumab

Intervention Type DRUG

5 mg bapineuzumab subcutaneous injection once per week for 6 months

B

10 mg/week

Group Type EXPERIMENTAL

bapineuzumab

Intervention Type DRUG

10 mg bapineuzumab subcutaneous injection once per week for 6 months

C

Placebo

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

Placebo subcutaneous injection once per week for 6 months

Interventions

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bapineuzumab

5 mg bapineuzumab subcutaneous injection once per week for 6 months

Intervention Type DRUG

bapineuzumab

10 mg bapineuzumab subcutaneous injection once per week for 6 months

Intervention Type DRUG

placebo

Placebo subcutaneous injection once per week for 6 months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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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Pfizer Investigational Site

Phoenix, Arizona, United States

Site Status

Pfizer Investigational Site

Sun City, Arizona, United States

Site Status

Pfizer Investigational Site

Encino, California, United States

Site Status

Pfizer Investigational Site

Los Alamitos, California, United States

Site Status

Pfizer Investigational Site

Newport Beach, California, United States

Site Status

Pfizer Investigational Site

Delray Beach, Florida, United States

Site Status

Pfizer Investigational Site

Hallandale, Florida, United States

Site Status

Pfizer Investigational Site

West Palm Beach, Florida, United States

Site Status

Pfizer Investigational Site

Decatur, Georgia, United States

Site Status

Pfizer Investigational Site

Lawrenceville, Georgia, United States

Site Status

Pfizer Investigational Site

Wichita, Kansas, United States

Site Status

Pfizer Investigational Site

Rochester, New York, United States

Site Status

Pfizer Investigational Site

East Providence, Rhode Island, United States

Site Status

Pfizer Investigational Site

Providence, Rhode Island, United States

Site Status

Pfizer Investigational Site

Dallas, Texas, United States

Site Status

Pfizer Investigational Site

Bennington, Vermont, United States

Site Status

Pfizer Investigational Site

Madison, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3133L1-2203&StudyName=Study%20Evaluating%20Bapineuzumab%20In%20Alzheimer%20Disease%20Subjects

To obtain contact information for a study center near you, click here.

Other Identifiers

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B2521008

Identifier Type: -

Identifier Source: secondary_id

3133L1-2203

Identifier Type: -

Identifier Source: org_study_id