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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: bapineuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00916617

B2521009 (Other Identifier)

3133L1-2204

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 50 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 1 patient group

1

Experimental group

Description:

5 mg/week

Treatment:

Drug: bapineuzumab