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

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Experimental Bapineuzumab

• Registration Number: NCT01254773
• Lead Sponsor: JANSSEN Alzheimer Immunotherapy Research & Development, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2010-12-03
• Study First Posted: 2010-12-07
• Primary Completion: 2013-01
• Study Completion: 2013-03
• Disposition First Submitted: 2014-02-26
• Disposition First Submitted QC: 2014-02-26
• Disposition First Posted: 2014-03-26
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-21
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bapineuzumab SC Dose 3; 20 mg	Experimental Bapineuzumab	-
Bapineuzumab SC Dose 1; 2 mg	Experimental Bapineuzumab	-
Bapineuzumab SC Dose 2; 7 mg	Experimental Bapineuzumab	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Janssen AI Investigational Site; 🇺🇸 Providence, Rhode Island, United States