A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease

Stopped early · Phase 3

Conditions studied: Alzheimer's Disease

In brief

The purpose of this study is to assess the long-term safety and tolerability of Bapineuzumab (AAB-001, ELN115727) in subjects with Alzheimer's disease who participated in study ELN115727-301 or study ELN115727-302.

Key facts

Study ID

NCT00937352

Run by

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

People needed

896

Starts

2009-07-01

Expected to finish

2012-09-01

Last updated by the study team

2013-12-20

Who can join

Age: 51 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of probable AD
• Must have completed study 301 or study 302; and have completed Visit 15 (Week 78)
• Brain MRI scan to evaluate safety from Study 301 or 302 at Visit 14/Week 71
• Caregiver able to attend all clinic visits with patient

You may not qualify if…

• Any new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs or ECG examination (eg, atrial fibrillation) that precludes continued or initiation of treatment with bapineuzumab or participation in the study
• Screening visit brain MRI scan (MRI from Study 301 or 302 Visit 14/Week 71) indicative of any significant abnormality not approved by the medical monitor prior to enrollment
• Current use of experimental medications for AD (other than bapineuzumab) and all other experimental medications, herbal preparations containing Ginko biloba, and anticoagulants (except the use of aspirin 325mg/day or less, Plavix, and Persantine but not for stroke)

Where it is running

• Dedicated Clinical Research, Inc. — Goodyear, Arizona, United States
• Banner Alzheimer's Institute — Phoenix, Arizona, United States
• HOPE Research Institute, LLC — Phoenix, Arizona, United States
• Banner Research Institute — Sun City, Arizona, United States
• University of Arizona College of Medicine, Health Sciences Center — Tucson, Arizona, United States
• Northwest NeuroSpecialists, PLLC — Tucson, Arizona, United States
• Clinical Trials, Inc. — Little Rock, Arkansas, United States
• East Bay Physicians Medical Group — Berkeley, California, United States
• AVI Clinical Research — Carson, California, United States
• ATP Clinical Research, Inc. — Costa Mesa, California, United States
• Pharmacology Research Institute — Encino, California, United States
• Margolin Brain Institute — Fresno, California, United States
• Neurology Center of North Orange County — Fullerton, California, United States
• Coordinated Clinical Research — La Jolla, California, United States
• University of California San Diego — La Jolla, California, United States
• Senior Clinical Trials, Inc. — Laguna Hills, California, United States
• Collaborative NeuroScience Network, Inc. — Long Beach, California, United States
• Pharmacology Research Institute — Los Alamitos, California, United States
• UCLA Department of Neurology — Los Angeles, California, United States
• Pharmacology Research Institute — Newport Beach, California, United States
• Neurology Center — Oceanside, California, United States
• University of California, Irvine Medical Center — Orange, California, United States
• Neuro-Therapeutics, Inc. — Pasadena, California, United States
• Sutter Neuroscience Medical Group — Sacramento, California, United States
• University of Alabama Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.