AAB-001 in Patients With Mild to Moderate Alzheimer's Disease
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
1 other identifier
interventional
234
1 country
26
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2005
Typical duration for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 27, 2005
CompletedFirst Posted
Study publicly available on registry
May 30, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedMarch 14, 2012
March 1, 2012
3.6 years
May 27, 2005
March 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
safety assessments
18 months
Secondary Outcomes (2)
blood levels of administered study drug
18 months
cognitive and functional assessments
18 months
Study Arms (8)
0.15 mg/kg active bapineuzumab
EXPERIMENTAL0.15 mg/kg placebo
PLACEBO COMPARATOR0.5 mg/kg active bapineuzumab
EXPERIMENTAL0.5 mg/kg placebo
PLACEBO COMPARATOR1.0 mg/kg active bapineuzumab
EXPERIMENTAL1.0 mg/kg placebo
PLACEBO COMPARATOR2.0 mg/kg active bapineuzumab
EXPERIMENTAL2.0 mg/kg placebo
PLACEBO COMPARATORInterventions
IV, Q13w
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Cleo Roberts Center for Clinical Research / Sun Health Research Institute
Sun City, Arizona, 85351, United States
UC Irvine
Irvine, California, 92697, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
Pharmacology Research Institute
Northridge, California, 91324, United States
UCSD Shiley-Marcos Alzheimer's Disease Research Center
San Diego, California, United States
Memory & Aging Center, UCSF
San Francisco, California, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20057, United States
Brain Matters Research, Inc.
Delray Beach, Florida, 33445, United States
Mayo Clinic - Department of Neurology
Jacksonville, Florida, 32224, United States
Rush Presbyterian St. Luke's Medical Center
Chicago, Illinois, 60612, United States
Department of Neurology - Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
Behavioral Neurology
Boston, Massachusetts, 02115, United States
University of Michigan Health System, Department of Neurology
Ann Arbor, Michigan, 48109, United States
Mayo Clinic Department of Neurology - Alzheimer's Disease Research Center
Rochester, Minnesota, 55905, United States
The Memory Enhancement Center
Long Branch, New Jersey, 07740, United States
Sergievsky Center, Columbia University
New York, New York, 10032, United States
University of Rochester / Monroe Community Hospital
Rochester, New York, 14620, United States
Department of Psychiatry and Behavioral Sciences
Durham, North Carolina, 27710, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Memory and Aging Program, Butler Hospital
Providence, Rhode Island, 02906, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Clinical Neuroscience Research Associates, Inc.
Bennington, Vermont, 05201, United States
University of Washington
Seattle, Washington, 98108, United States
Related Publications (2)
Arrighi HM, Barakos J, Barkhof F, Tampieri D, Jack C Jr, Melancon D, Morris K, Ketter N, Liu E, Brashear HR. Amyloid-related imaging abnormalities-haemosiderin (ARIA-H) in patients with Alzheimer's disease treated with bapineuzumab: a historical, prospective secondary analysis. J Neurol Neurosurg Psychiatry. 2016 Jan;87(1):106-12. doi: 10.1136/jnnp-2014-309493. Epub 2015 Feb 10.
PMID: 25669746DERIVEDBlennow K, Zetterberg H, Rinne JO, Salloway S, Wei J, Black R, Grundman M, Liu E; AAB-001 201/202 Investigators. Effect of immunotherapy with bapineuzumab on cerebrospinal fluid biomarker levels in patients with mild to moderate Alzheimer disease. Arch Neurol. 2012 Aug;69(8):1002-10. doi: 10.1001/archneurol.2012.90.
PMID: 22473769DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2005
First Posted
May 30, 2005
Study Start
April 1, 2005
Primary Completion
November 1, 2008
Study Completion
December 1, 2008
Last Updated
March 14, 2012
Record last verified: 2012-03