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

Stopped early · Phase 3

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT00998764

Run by

Pfizer

People needed

494

Starts

2009-12-01

Expected to finish

2012-11-01

Last updated by the study team

2016-01-01

Who can join

Age: 51 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UAB Center for Psychiatric Medicine — Birmingham, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Alabama-Birmingham — Birmingham, Alabama, United States
• Dedicated Clinical Research — Goodyear, Arizona, United States
• Banner Alzheimer's Institute — Phoenix, Arizona, United States
• Banner Good Samaritan Medical Center (Imaging — Phoenix, Arizona, United States
• Jeffrey S. Gitt — Phoenix, Arizona, United States
• Hope Research Institute — Phoenix, Arizona, United States
• Clinical Trials, Inc. — Little Rock, Arkansas, United States
• San Francisco Clinical Research Center — San Francisco, California, United States
• Alpine Clinical Research Center, Inc. — Boulder, Colorado, United States
• Associated Neurologist, PC — Boulder, Colorado, United States
• Mile High Research Center — Denver, Colorado, United States
• Associated Neurologists of Southern Connecticut, P.C. — Fairfield, Connecticut, United States
• Bendheim Infusion Center, Greenwich Hospital — Greenwich, Connecticut, United States
• Center for Healthy Aging, Greenwich Hospital — Greenwich, Connecticut, United States
• Research Center for Clinical Studies, Inc. — Norwalk, Connecticut, United States
• JEM Research LLC — Atlantis, Florida, United States
• Medical Specialists of the Palm Beaches — Atlantis, Florida, United States
• Brain Matters Research — Delray Beach, Florida, United States
• Compass Research, LLC — Orlando, Florida, United States
• Palm Beach Neurological Center, Advanced Research Consultants, Inc. — Palm Beach Gardens, Florida, United States
• Neurostudies, Inc — Port Charlotte, Florida, United States
• Southwest Florida Infusion Care, Inc. — Port Charlotte, Florida, United States
• University Of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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