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

Alzheimer's Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254773
• Other study ID #: AAB-001-SC-ALZ-2003
• Status: Completed
• Phase: Phase 2
• First received: December 3, 2010
• Last updated: April 21, 2014
• Start date: December 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2014
• Source: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 89 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Experimental Bapineuzumab
Bapineuzumab 2 mg, Bapineuzumab 7 mg, Bapineuzumab 20 mg, Placebo

Locations

Country	Name	City	State
United States	Janssen AI Investigational Site	Atlanta	Georgia
United States	Janssen AI Investigational Site	Creve Coeur	Missouri
United States	Janssen AI Investigational Site	Dayton	Ohio
United States	Janssen AI Investigational Site	Deerfield Beach	Florida
United States	Janssen AI Investigational Site	Delray Beach	Florida
United States	Janssen AI Investigational Site	Farmington Hills	Michigan
United States	Janssen AI Investigational Site	Fort Meyers	Florida
United States	Janssen AI Investigational Site	Indianapolis	Indiana
United States	Janssen AI Investigational Site	Kansas City	Kansas
United States	Janssen AI Investigational Site	La Habra	California
United States	Janssen AI Investigational Site	Latham	New York
United States	Janssen AI Investigational Site	Lexington	Kentucky
United States	Janssen AI Investigational Site	Lomita	California
United States	Janssen AI Investigational Site	Long Beach	California
United States	Janssen AI Investigational Site	Miami Springs	Florida
United States	Janssen AI Investigational Site	Oceanside	California
United States	Janssen AI Investigational Site	Pasadena	California
United States	Janssen AI Investigational Site	Philadelphia	Pennsylvania
United States	Janssen AI Investigational Site	Plymouth	Massachusetts
United States	Janssen AI Investigational Site	Portland	Oregon
United States	Janssen AI Investigational Site	Providence	Rhode Island
United States	Janssen AI Investigational Site	Santa Monica	California
United States	Janssen AI Investigational Site	Sherman Oaks	California
United States	Janssen AI Investigational Site	South Miami	Florida
United States	Janssen AI Investigational Site	St. Louis	Missouri
United States	Janssen AI Investigational Site	Tucson	Arizona
United States	Janssen AI Investigational Site	Tucson	Arizona
United States	Janssen AI Investigational Site	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
JANSSEN Alzheimer Immunotherapy Research & Development, LLC	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To assess the safety of bapineuzumab administered SC at monthly intervals compared to placebo in subjects with mild to moderate AD		24 months	Yes
Secondary	To assess the effect of bapineuzumab administered SC at monthly intervals compared to placebo on cognitive and functional endpoints.		24 months	No