Safety Study of Passive Immunization for Patients With Mild to Moderate Alzheimer's Disease

• Status: Unknown status
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2

Details

• Lead Sponsor: Pharmacology Research Institute

Criteria

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