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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00112073
First received: May 27, 2005
Last updated: March 12, 2012
Last verified: March 2012

May 27, 2005
March 12, 2012
April 2005
November 2008   (final data collection date for primary outcome measure)
safety assessments [ Time Frame: 18 months ]
safety assessments
Complete list of historical versions of study NCT00112073 on ClinicalTrials.gov Archive Site
  • blood levels of administered study drug [ Time Frame: 18 months ]
  • cognitive and functional assessments [ Time Frame: 18 months ]
  • blood levels of administered study drug
  • cognitive and functional assessments
Not Provided
Not Provided
 
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

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: bapineuzumab
    IV, Q13w
    Other Name: AAB-001
  • Other: placebo
    IV Q13w
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
234
December 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00112073
AAB-001-201
Not Provided
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer
Not Provided
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
March 2012

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