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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
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112073

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

No publications provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Additional 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
Study First Received: May 27, 2005
Last Updated: March 12, 2012
Health Authority: United States: Food and Drug Administration

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013