Safety Study of Passive Immunization for Patients With Mild to Moderate Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT00174525
Recruitment Status : Unknown
Verified May 2012 by Pharmacology Research Institute. Recruitment status was: Active, not recruiting
This research study will assess whether AAB-001 is safe, well tolerated and effective for use in patients with Alzheimer's Disease. AAB-001 is a new drug that is not available outside this study. AAB-001 is an antibody (a type of protein usually produced by white blood cells to destroy other substances in the body). In Alzheimer's disease a protein called amyloid gathers in the brain and is thought to cause symptoms like memory loss and confusion. It is hoped that AAB-001 will attach to the amyloid protein in your brain and help your body to remove it.
A Phase IIA, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Immunogenicity Trial of AAB-001 in Patients With Mild to Moderate AD
Study Start Date :
Study Completion Date :
Resource links provided by the National Library of Medicine
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Ages Eligible for Study:
50 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:
Diagnosis of probable AD
Age from 50 to 85 years, inclusive
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
Significant neurological disease other than AD
Major psychiatric disorder
Significant systemic illness
History of stroke or seizure
Weight greater than 120kg (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