Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00112073
Recruitment Status : Completed
First Posted : May 30, 2005
Last Update Posted : March 14, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE May 27, 2005
First Posted Date  ICMJE May 30, 2005
Last Update Posted Date March 14, 2012
Study Start Date  ICMJE April 2005
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
safety assessments [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
safety assessments
Change History Complete list of historical versions of study NCT00112073 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
  • blood levels of administered study drug [ Time Frame: 18 months ]
  • cognitive and functional assessments [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • blood levels of administered study drug
  • cognitive and functional assessments
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AAB-001 in Patients With Mild to Moderate Alzheimer's Disease
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: bapineuzumab
    IV, Q13w
    Other Name: AAB-001
  • Other: placebo
    IV Q13w
Study Arms  ICMJE
  • Experimental: 0.15 mg/kg active bapineuzumab
    Intervention: Drug: bapineuzumab
  • Placebo Comparator: 0.15 mg/kg placebo
    Intervention: Other: placebo
  • Experimental: 0.5 mg/kg active bapineuzumab
    Intervention: Drug: bapineuzumab
  • Placebo Comparator: 0.5 mg/kg placebo
    Intervention: Other: placebo
  • Experimental: 1.0 mg/kg active bapineuzumab
    Intervention: Drug: bapineuzumab
  • Placebo Comparator: 1.0 mg/kg placebo
    Intervention: Other: placebo
  • Experimental: 2.0 mg/kg active bapineuzumab
    Intervention: Drug: bapineuzumab
  • Placebo Comparator: 2.0 mg/kg placebo
    Intervention: Other: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2009)
234
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
180
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00112073
Other Study ID Numbers  ICMJE AAB-001-201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Sponsor  ICMJE JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP