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AAB-001 in Patients With Mild to Moderate Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bapineuzumab
placebo
Sponsored by
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, immunotherapy, beta amyloid

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleo Roberts Center for Clinical Research / Sun Health Research Institute
  • UC Irvine
  • Pharmacology Research Institute
  • Pharmacology Research Institute
  • UCSD Shiley-Marcos Alzheimer's Disease Research Center
  • Memory & Aging Center, UCSF
  • Yale University School of Medicine
  • Georgetown University Medical Center
  • Brain Matters Research, Inc.
  • Mayo Clinic - Department of Neurology
  • Rush Presbyterian St. Luke's Medical Center
  • Department of Neurology - Indiana University Medical Center
  • Behavioral Neurology
  • University of Michigan Health System, Department of Neurology
  • Mayo Clinic Department of Neurology - Alzheimer's Disease Research Center
  • The Memory Enhancement Center
  • Sergievsky Center, Columbia University
  • University of Rochester / Monroe Community Hospital
  • Department of Psychiatry and Behavioral Sciences
  • Oregon Health and Science University
  • University of Pittsburgh
  • Memory and Aging Program, Butler Hospital
  • University of Texas Southwestern Medical Center
  • Baylor College of Medicine
  • Clinical Neuroscience Research Associates, Inc.
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

0.15 mg/kg active bapineuzumab

0.15 mg/kg placebo

0.5 mg/kg active bapineuzumab

0.5 mg/kg placebo

1.0 mg/kg active bapineuzumab

1.0 mg/kg placebo

2.0 mg/kg active bapineuzumab

2.0 mg/kg placebo

Arm Description

Outcomes

Primary Outcome Measures

safety assessments

Secondary Outcome Measures

blood levels of administered study drug
cognitive and functional assessments

Full Information

First Posted
May 27, 2005
Last Updated
March 12, 2012
Sponsor
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00112073
Brief Title
AAB-001 in Patients With Mild to Moderate Alzheimer's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborators
Pfizer

4. Oversight

5. Study Description

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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease, immunotherapy, beta amyloid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.15 mg/kg active bapineuzumab
Arm Type
Experimental
Arm Title
0.15 mg/kg placebo
Arm Type
Placebo Comparator
Arm Title
0.5 mg/kg active bapineuzumab
Arm Type
Experimental
Arm Title
0.5 mg/kg placebo
Arm Type
Placebo Comparator
Arm Title
1.0 mg/kg active bapineuzumab
Arm Type
Experimental
Arm Title
1.0 mg/kg placebo
Arm Type
Placebo Comparator
Arm Title
2.0 mg/kg active bapineuzumab
Arm Type
Experimental
Arm Title
2.0 mg/kg placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
bapineuzumab
Other Intervention Name(s)
AAB-001
Intervention Description
IV, Q13w
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
IV Q13w
Primary Outcome Measure Information:
Title
safety assessments
Time Frame
18 months
Secondary Outcome Measure Information:
Title
blood levels of administered study drug
Time Frame
18 months
Title
cognitive and functional assessments
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cleo Roberts Center for Clinical Research / Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
UC Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Pharmacology Research Institute
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
UCSD Shiley-Marcos Alzheimer's Disease Research Center
City
San Diego
State/Province
California
Country
United States
Facility Name
Memory & Aging Center, UCSF
City
San Francisco
State/Province
California
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
Brain Matters Research, Inc.
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Mayo Clinic - Department of Neurology
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Rush Presbyterian St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Department of Neurology - Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Behavioral Neurology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan Health System, Department of Neurology
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic Department of Neurology - Alzheimer's Disease Research Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
The Memory Enhancement Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740
Country
United States
Facility Name
Sergievsky Center, Columbia University
City
New York City
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester / Monroe Community Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Department of Psychiatry and Behavioral Sciences
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Memory and Aging Program, Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Neuroscience Research Associates, Inc.
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25669746
Citation
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.
Results Reference
derived
PubMed Identifier
22473769
Citation
Blennow 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.
Results Reference
derived

Learn more about this trial

AAB-001 in Patients With Mild to Moderate Alzheimer's Disease

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