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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Experimental Bapineuzumab
Sponsored by
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site
  • Janssen AI Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Bapineuzumab SC Dose 1; 2 mg

Bapineuzumab SC Dose 2; 7 mg

Bapineuzumab SC Dose 3; 20 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 3, 2010
Last Updated
April 21, 2014
Sponsor
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01254773
Brief Title
Amyloid Imaging And Safety Study Of Subcutaneous Bapineuzumab In Subjects With Mild to Moderate Alzheimer's Disease
Acronym
SUMMIT AD
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 Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bapineuzumab SC Dose 1; 2 mg
Arm Type
Experimental
Arm Title
Bapineuzumab SC Dose 2; 7 mg
Arm Type
Experimental
Arm Title
Bapineuzumab SC Dose 3; 20 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Experimental Bapineuzumab
Intervention Description
Bapineuzumab 2 mg, Bapineuzumab 7 mg, Bapineuzumab 20 mg, Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
To assess the effect of bapineuzumab administered SC at monthly intervals compared to placebo on cognitive and functional endpoints.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Janssen AI Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Janssen AI Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Janssen AI Investigational Site
City
La Habra
State/Province
California
ZIP/Postal Code
90631
Country
United States
Facility Name
Janssen AI Investigational Site
City
Lomita
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Janssen AI Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Janssen AI Investigational Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Janssen AI Investigational Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Janssen AI Investigational Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Janssen AI Investigational Site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Janssen AI Investigational Site
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Janssen AI Investigational Site
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Janssen AI Investigational Site
City
Fort Meyers
State/Province
Florida
ZIP/Postal Code
33919
Country
United States
Facility Name
Janssen AI Investigational Site
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Janssen AI Investigational Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Janssen AI Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Janssen AI Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Janssen AI Investigational Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Janssen AI Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Janssen AI Investigational Site
City
Plymouth
State/Province
Massachusetts
ZIP/Postal Code
02360
Country
United States
Facility Name
Janssen AI Investigational Site
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Janssen AI Investigational Site
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Janssen AI Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Janssen AI Investigational Site
City
Latham
State/Province
New York
ZIP/Postal Code
12210
Country
United States
Facility Name
Janssen AI Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Janssen AI Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Janssen AI Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Janssen AI Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Janssen AI Investigational Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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