AAB-001 in 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: Completed

Administrative data

• NCT number: NCT00112073
• Other study ID #: AAB-001-201
• Status: Completed
• Phase: Phase 2
• First received: May 27, 2005
• Last updated: March 12, 2012
• Start date: April 2005
• Est. completion date: December 2008

Study information

• Verified date: March 2012
• Source: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and tolerability of multiple doses of AAB-001 passive immunization in patients with mild to moderate Alzheimer's disease (AD).

Description:

The humanized monoclonal antibody, AAB-001, which binds to and clears beta amyloid peptide, is designed to provide antibodies to beta amyloid directly to the patient, rather than requiring the patient to mount his/her own individual response. It is believed that this approach may eliminate the need for the patient to mount an immune response to beta amyloid. Animal studies have shown that this approach is equally effective in clearing beta amyloid from the brain as traditional active immunization methods.

This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple ascending dose study in male and female patients aged 50 to 85 years with mild to moderate AD. Approximately 30 study sites will be involved. Patients will be randomized to receive either AAB-001 or placebo. Each patient's participation will last approximately 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Diagnosis of probable AD

• Age from 50 to 85 years

• 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 120 kg (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 (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• bapineuzumab
IV, Q13w

Other:
• placebo
IV Q13w

Locations

Country	Name	City	State
United States	University of Michigan Health System, Department of Neurology	Ann Arbor	Michigan
United States	Clinical Neuroscience Research Associates, Inc.	Bennington	Vermont
United States	Behavioral Neurology	Boston	Massachusetts
United States	Rush Presbyterian St. Luke's Medical Center	Chicago	Illinois
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Brain Matters Research, Inc.	Delray Beach	Florida
United States	Department of Psychiatry and Behavioral Sciences	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Department of Neurology - Indiana University Medical Center	Indianapolis	Indiana
United States	UC Irvine	Irvine	California
United States	Mayo Clinic - Department of Neurology	Jacksonville	Florida
United States	The Memory Enhancement Center	Long Branch	New Jersey
United States	Pharmacology Research Institute	Los Alamitos	California
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Sergievsky Center, Columbia University	New York City	New York
United States	Pharmacology Research Institute	Northridge	California
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Memory and Aging Program, Butler Hospital	Providence	Rhode Island
United States	Mayo Clinic Department of Neurology - Alzheimer's Disease Research Center	Rochester	Minnesota
United States	University of Rochester / Monroe Community Hospital	Rochester	New York
United States	UCSD Shiley-Marcos Alzheimer's Disease Research Center	San Diego	California
United States	Memory & Aging Center, UCSF	San Francisco	California
United States	University of Washington	Seattle	Washington
United States	Cleo Roberts Center for Clinical Research / Sun Health Research Institute	Sun City	Arizona
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
JANSSEN Alzheimer Immunotherapy Research & Development, LLC	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety assessments		18 months
Secondary	blood levels of administered study drug		18 months
Secondary	cognitive and functional assessments		18 months