A Phase 3 Extension, Multicenter, Long Term Safety And Tolerability Trial Of Bapineuzumab (Aab 001, Eln115727) In Subjects With Alzheimer Disease Who Are Apolipoprotein E 4 Carriers And Participated In Study 3133k1-3001-us Or Study 3133k1-3001-ww.

Pfizer180 sites in 1 country494 target enrollmentDecember 2009

ConditionsAlzheimer Disease

InterventionsBapineuzumab 0.5 mg/kg

DrugsBapineuzumab 0.5 mg/kg

Overview

Phase: Phase 3
Intervention: Bapineuzumab 0.5 mg/kg
Conditions: Alzheimer Disease
Sponsor: Pfizer
Enrollment: 494
Locations: 180
Primary Endpoint: Number of Participants Reporting a Serious Adverse Event
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

November 2012

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Bapineuzumab 0.5 mg/kg

Intervention: Bapineuzumab 0.5 mg/kg

Outcomes

Primary Outcomes

Number of Participants Reporting a Serious Adverse Event

Time Frame: Up to Week 195

Safety was measured according to standard adverse event collection as described in the Adverse Event Section of the Results. Complete tables of events are provided there.

Secondary Outcomes

Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78(Base Study Baseline, Weeks 13, 26, 39, 52 and 78)
Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.(Base Study Baseline, Weeks 13, 26, 39, 52 and 78)
Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.(Base Study Baseline, Weeks 13, 26, 39, 52 and 78)
Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.(Base Study Baseline, Weeks 26, 52 and 78)
Change From Extension Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.(Base Study Baseline, Weeks 13, 26, 39, 52 and 78)
Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.(Base Study Baseline, Weeks 6, 19, 32, 45 and 78)
Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.(Base Study Baseline, Weeks 26, 52 and 78)
Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.(Base Study Baseline, Weeks 6, 19, 32, 45 and 78)