A Long-Term Safety And Tolerability Extension Study Of Bapineuzumab In Alzheimer Disease Patients

Pfizer

Status and phase

Terminated

Phase 3

Conditions

Alzheimer Disease

Treatments

Drug: Bapineuzumab 0.5 mg/kg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00998764

B2521004 (Other Identifier)

2009-015080-13 (EudraCT Number)

3133K1-3003

Details and patient eligibility

About

The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab in subjects with Alzheimer Disease who participated in study 3133K1-3001(NCT00676143). Over 250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each subject's participation will last approximately 4 years.

Enrollment

494 patients

Sex

All

Ages

51 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject has completed study 3133K1-3001 (Week 78) and brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of Alzheimer Disease
Mini-Mental Status Examination (MMSE) >=10 at screening
Caregiver able to attend all clinic visits with subject

Exclusion criteria

Any medical or psychiatric contraindication or clinically significant abnormality that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response.
Any significant brain MRI abnormality.
Use of any investigational drugs or devices, other than bapineuzumab within the last 60 days prior to screening