Clinical trial NCT01254773: Amyloid Imaging And Safety Study Of Subcutaneous Bapineuzumab In Subjects With Mild to Moderate Alzheimer's Disease
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2010-12-07
Enrollment: 146
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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.
timeFrame: 24 months
Secondary outcomes:
measure: To assess the safety of bapineuzumab administered SC at monthly intervals compared to placebo in subjects with mild to moderate AD
timeFrame: 24 months
measure: To assess the effect of bapineuzumab administered SC at monthly intervals compared to placebo on cognitive and functional endpoints.
timeFrame: 24 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Janssen AI Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Janssen AI Investigational Site
state: Arizona
city: La Habra
country: United States
facility: Janssen AI Investigational Site
state: California
city: Lomita
country: United States
facility: Janssen AI Investigational Site
state: California
city: Long Beach
country: United States
facility: Janssen AI Investigational Site
state: California
city: Oceanside
country: United States
facility: Janssen AI Investigational Site
state: California
city: Pasadena
country: United States
facility: Janssen AI Investigational Site
state: California
city: Santa Monica
country: United States
facility: Janssen AI Investigational Site
state: California
city: Sherman Oaks
country: United States
facility: Janssen AI Investigational Site
state: California
city: Deerfield Beach
country: United States
facility: Janssen AI Investigational Site
state: Florida
city: Delray Beach
country: United States
facility: Janssen AI Investigational Site
state: Florida
city: Fort Meyers
country: United States
facility: Janssen AI Investigational Site
state: Florida
city: Miami Springs
country: United States
facility: Janssen AI Investigational Site
state: Florida
city: South Miami
country: United States
facility: Janssen AI Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Janssen AI Investigational Site
state: Georgia
city: Indianapolis
country: United States
facility: Janssen AI Investigational Site
state: Indiana
city: Kansas City
country: United States
facility: Janssen AI Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Janssen AI Investigational Site
state: Kentucky
city: Plymouth
country: United States
facility: Janssen AI Investigational Site
state: Massachusetts
city: Farmington Hills
country: United States
facility: Janssen AI Investigational Site
state: Michigan
city: Creve Coeur
country: United States
facility: Janssen AI Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Janssen AI Investigational Site
state: Missouri
city: Latham
country: United States
facility: Janssen AI Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: Janssen AI Investigational Site
state: North Carolina
city: Dayton
country: United States
facility: Janssen AI Investigational Site
state: Ohio
city: Portland
country: United States
facility: Janssen AI Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Janssen AI Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: Janssen AI Investigational Site
state: Rhode Island
Study officials:
References: