Title
Safety Study of Passive Immunization for Patients With Mild to Moderate Alzheimer's Disease
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
Phase
Phase 2Lead Sponsor
Pharmacology Research InstituteStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Alzheimer's DiseaseIntervention/Treatment
bapineuzumab ...Study Participants
NoneThis 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.
Inclusion Criteria: 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 Exclusion Criteria: 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