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

JANSSEN Alzheimer Immunotherapy Research & Development, LLC1 site in 1 country146 target enrollmentDecember 2010

ConditionsAlzheimer's Disease

InterventionsExperimental Bapineuzumab

DrugsExperimental Bapineuzumab

Overview

Phase: Phase 2
Intervention: Experimental Bapineuzumab
Conditions: Alzheimer's Disease
Sponsor: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Enrollment: 146
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

March 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Responsible Party

Sponsor

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

Arms & Interventions

Bapineuzumab SC Dose 1; 2 mg

Intervention: Experimental Bapineuzumab

Bapineuzumab SC Dose 2; 7 mg

Intervention: Experimental Bapineuzumab

Bapineuzumab SC Dose 3; 20 mg

Intervention: Experimental Bapineuzumab

Outcomes

Primary Outcomes

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 Outcomes

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