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

Pharmacology Research Institute

Status and phase: Unknown; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: AAB-001

Study type: Interventional

Funder types: Other

Identifiers

NCT00174525

PRI#585

Details and patient eligibility

About

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.

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind