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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00174525
• Other study ID #: PRI#585
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: May 8, 2012
• Start date: April 2005
• Est. completion date: April 2008

Study information

• Verified date: May 2012
• Source: Pharmacology Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Est. completion date: April 2008
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• AAB-001

Locations

Country	Name	City	State
United States	Pharmacology Research Institute	Los Alamitos	California
United States	Pharmacology Research Institute	Northridge	California

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacology Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessments
Secondary	Blood levels of administered study drug
Secondary	Cognitive and functional assessments