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

Phase 2

• Conditions: Alzheimer's Disease

• Registration Number: NCT00174525
• Lead Sponsor: Pharmacology Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Study Completion: 2008-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-08
• Last Update Posted: 2012-05-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety assessments

Secondary Outcome Measures

Name	Time	Method
Blood levels of administered study drug
Cognitive and functional assessments

Trial Locations

Locations (1)

Pharmacology Research Institute; 🇺🇸 Northridge, California, United States