Study Evaluating Bapineuzumab In Alzheimer Disease Subjects

Pfizer

Status and phase: Completed; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: bapineuzumab; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00663026

3133L1-2203

B2521008

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 50 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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79 participants in 3 patient groups

A

Experimental group

Description:

5 mg/week

Treatment:

Drug: bapineuzumab

Drug: bapineuzumab

B

Experimental group

Description:

10 mg/week

Treatment:

Drug: bapineuzumab

Drug: bapineuzumab

C

Experimental group

Description:

Placebo

Treatment:

Drug: placebo