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

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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: Experimental Bapineuzumab

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Janssen AI Investigational Site
    • Tucson, Arizona, United States, 85741
      • Janssen AI Investigational Site
  • California
    • 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
      • Janssen AI Investigational Site
  • Florida
    • 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
      • Janssen AI Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Janssen AI Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Janssen AI Investigational Site
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Janssen AI Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Janssen AI Investigational Site
  • Massachusetts
    • Plymouth, Massachusetts, United States, 02360
      • Janssen AI Investigational Site
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Janssen AI Investigational Site
  • Missouri
    • Creve Coeur, Missouri, United States, 63141
      • Janssen AI Investigational Site
    • St. Louis, Missouri, United States, 63104
      • Janssen AI Investigational Site
  • New York
    • Latham, New York, United States, 12210
      • Janssen AI Investigational Site
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Janssen AI Investigational Site
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Janssen AI Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97239
      • Janssen AI Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Janssen AI Investigational Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Janssen AI Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
• Collaborators: Pfizer

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: December 3, 2010
• First Submitted That Met QC Criteria: December 3, 2010
• First Posted (Estimate): December 7, 2010

Study Record Updates

• Last Update Posted (Estimate): May 9, 2014
• Last Update Submitted That Met QC Criteria: April 21, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: AAB-001-SC-ALZ-2003