Safety Study of Passive Immunization for Patients With Mild to Moderate Alzheimer's Disease
This trial is active, not recruiting.
|Sponsor||Pharmacology Research Institute|
|Start date||April 2005|
|End date||April 2008|
|Trial identifier||NCT00174525, PRI#585|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety study|
|Intervention model||parallel assignment|
Blood levels of administered study drug
Cognitive and functional assessments
Male or female participants from 50 years up to 85 years old.
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
|Official title||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|
|Principal investigator||Daniel E. Grosz, MD|
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