AAB-001 in Patients With Mild to Moderate Alzheimer's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

The purpose of this study is to assess the safety and tolerability of multiple doses of AAB-001 passive immunization in patients with mild to moderate Alzheimer's disease (AD).

Key facts

Study ID

NCT00112073

Run by

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

People needed

234

Starts

2005-04-01

Expected to finish

2008-12-01

Last updated by the study team

2012-03-14

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of probable AD
• Age from 50 to 85 years
• Rosen Modified Hachinski Ischemic score less than or equal to 4
• Magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
• Fluency in English
• Stable doses of medications

You may not qualify if…

• Significant neurological disease other than AD
• Major psychiatric disorder
• Significant systemic illness
• History of stroke or seizure
• Weight greater than 120 kg (264 lbs.)
• History of autoimmune disease
• Smoking more than 20 cigarettes per day
• Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
• Prior treatment with experimental immunotherapeutics or vaccines for AD
• Presence of pacemakers or foreign metal objects in the eyes, skin, or body

Where it is running

• Cleo Roberts Center for Clinical Research / Sun Health Research Institute — Sun City, Arizona, United States
• UC Irvine — Irvine, California, United States
• Pharmacology Research Institute — Los Alamitos, California, United States
• Pharmacology Research Institute — Northridge, California, United States
• UCSD Shiley-Marcos Alzheimer's Disease Research Center — San Diego, California, United States
• Memory & Aging Center, UCSF — San Francisco, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Brain Matters Research, Inc. — Delray Beach, Florida, United States
• Mayo Clinic - Department of Neurology — Jacksonville, Florida, United States
• Rush Presbyterian St. Luke's Medical Center — Chicago, Illinois, United States
• Department of Neurology - Indiana University Medical Center — Indianapolis, Indiana, United States
• Behavioral Neurology — Boston, Massachusetts, United States
• University of Michigan Health System, Department of Neurology — Ann Arbor, Michigan, United States
• Mayo Clinic Department of Neurology - Alzheimer's Disease Research Center — Rochester, Minnesota, United States
• The Memory Enhancement Center — Long Branch, New Jersey, United States
• Sergievsky Center, Columbia University — New York, New York, United States
• University of Rochester / Monroe Community Hospital — Rochester, New York, United States
• Department of Psychiatry and Behavioral Sciences — Durham, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Memory and Aging Program, Butler Hospital — Providence, Rhode Island, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Clinical Neuroscience Research Associates, Inc. — Bennington, Vermont, United States

Full record on ClinicalTrials.gov

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