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Amyloid Imaging And Safety Study Of Subcutaneous Bapineuzumab In Subjects With Mild to Moderate Alzheimer's Disease (SUMMIT AD)

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: NCT01254773
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : May 9, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Study Description
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Brief Summary:
This study in individuals with mild to moderate Alzheimer's Disease is designed to assess:(1) safety and tolerability (2) the capacity of subcutaneous bapineuzumab to reduce brain amyloid load as measured by positron emission tomography (PET) scans.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Experimental Bapineuzumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center, Biomarker, Safety, and Pharmacokinetic Study of Bapineuzumab (AAB-001) Administered Subcutaneously at Monthly Intervals in Subjects With Mild to Moderate Alzheimer's Disease
Study Start Date : December 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Bapineuzumab SC Dose 1; 2 mg Drug: Experimental Bapineuzumab
Bapineuzumab 2 mg, Bapineuzumab 7 mg, Bapineuzumab 20 mg, Placebo
Experimental: Bapineuzumab SC Dose 2; 7 mg Drug: Experimental Bapineuzumab
Bapineuzumab 2 mg, Bapineuzumab 7 mg, Bapineuzumab 20 mg, Placebo
Experimental: Bapineuzumab SC Dose 3; 20 mg Drug: Experimental Bapineuzumab
Bapineuzumab 2 mg, Bapineuzumab 7 mg, Bapineuzumab 20 mg, Placebo
Placebo Comparator: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the effect of bapineuzumab administered subcutaneously (SC) at monthly intervals compared to placebo on cerebral amyloid burden in subjects with mild to moderate AD. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. To assess the safety of bapineuzumab administered SC at monthly intervals compared to placebo in subjects with mild to moderate AD [ Time Frame: 24 months ]
  2. To assess the effect of bapineuzumab administered SC at monthly intervals compared to placebo on cognitive and functional endpoints. [ Time Frame: 24 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable AD
  • Age from 50 to less than 89
  • Mini-Mental Status Exam score of 18-26 inclusive
  • Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
  • Stable doses of medications (cholinesterase inhibitors and memantine allowed)
  • Caregiver able to attend all clinic visits with patient
  • Amyloid burden on screening PET scan consistent with diagnosis of AD

Exclusion Criteria:

  • Significant neurological disease other than AD
  • Major psychiatric disorder
  • Significant systemic illness
  • History of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years
  • Smoking greater than 20 cigarettes per day
  • Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
  • Prior treatment experimental immunotherapeutics or vaccines for AD
  • Women of childbearing potential
  • Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body
Contacts and Locations
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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): NCT01254773


Locations
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United States, Arizona
Janssen AI Investigational Site
Tucson, Arizona, United States, 85724
Janssen AI Investigational Site
Tucson, Arizona, United States, 85741
United States, California
Janssen AI Investigational Site
La Habra, California, United States, 90631
Janssen AI Investigational Site
Lomita, California, United States, 90277
Janssen AI Investigational Site
Long Beach, California, United States, 90806
Janssen AI Investigational Site
Oceanside, California, United States, 92056
Janssen AI Investigational Site
Pasadena, California, United States, 91105
Janssen AI Investigational Site
Santa Monica, California, United States, 90404
Janssen AI Investigational Site
Sherman Oaks, California, United States, 91403
United States, Florida
Janssen AI Investigational Site
Deerfield Beach, Florida, United States, 33064
Janssen AI Investigational Site
Delray Beach, Florida, United States, 33445
Janssen AI Investigational Site
Fort Meyers, Florida, United States, 33919
Janssen AI Investigational Site
Miami Springs, Florida, United States, 33166
Janssen AI Investigational Site
South Miami, Florida, United States, 33143
United States, Georgia
Janssen AI Investigational Site
Atlanta, Georgia, United States, 30322
United States, Indiana
Janssen AI Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Kansas
Janssen AI Investigational Site
Kansas City, Kansas, United States, 66160
United States, Kentucky
Janssen AI Investigational Site
Lexington, Kentucky, United States, 40536
United States, Massachusetts
Janssen AI Investigational Site
Plymouth, Massachusetts, United States, 02360
United States, Michigan
Janssen AI Investigational Site
Farmington Hills, Michigan, United States, 48334
United States, Missouri
Janssen AI Investigational Site
Creve Coeur, Missouri, United States, 63141
Janssen AI Investigational Site
St. Louis, Missouri, United States, 63104
United States, New York
Janssen AI Investigational Site
Latham, New York, United States, 12210
United States, North Carolina
Janssen AI Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Janssen AI Investigational Site
Dayton, Ohio, United States, 45417
United States, Oregon
Janssen AI Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Janssen AI Investigational Site
Philadelphia, Pennsylvania, United States, 19102
United States, Rhode Island
Janssen AI Investigational Site
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer
More Information
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Responsible Party: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01254773    
Other Study ID Numbers: AAB-001-SC-ALZ-2003
First Posted: December 7, 2010    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders