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Trial record 14 of 14 for:    bapineuzumab

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00112073
First Posted: May 30, 2005
Last Update Posted: March 14, 2012
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.
Collaborator:
Pfizer
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
  Purpose
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).

Condition Intervention Phase
Alzheimer's Disease Drug: bapineuzumab Other: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:

Primary Outcome Measures:
  • safety assessments [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • blood levels of administered study drug [ Time Frame: 18 months ]
  • cognitive and functional assessments [ Time Frame: 18 months ]

Enrollment: 234
Study Start Date: April 2005
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.15 mg/kg active bapineuzumab Drug: bapineuzumab
IV, Q13w
Other Name: AAB-001
Placebo Comparator: 0.15 mg/kg placebo Other: placebo
IV Q13w
Experimental: 0.5 mg/kg active bapineuzumab Drug: bapineuzumab
IV, Q13w
Other Name: AAB-001
Placebo Comparator: 0.5 mg/kg placebo Other: placebo
IV Q13w
Experimental: 1.0 mg/kg active bapineuzumab Drug: bapineuzumab
IV, Q13w
Other Name: AAB-001
Placebo Comparator: 1.0 mg/kg placebo Other: placebo
IV Q13w
Experimental: 2.0 mg/kg active bapineuzumab Drug: bapineuzumab
IV, Q13w
Other Name: AAB-001
Placebo Comparator: 2.0 mg/kg placebo Other: placebo
IV Q13w

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00112073


  Show 26 Study Locations
Sponsors and Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00112073     History of Changes
Other Study ID Numbers: AAB-001-201
First Submitted: May 27, 2005
First Posted: May 30, 2005
Last Update Posted: March 14, 2012
Last Verified: March 2012

Keywords provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:
Alzheimer's disease
immunotherapy
beta amyloid

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders