A Phase 2, 24-Month, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Amyloid-Imaging Positron Emission Tomography (PET) and Safety Study of ACC-001 and QS-21 Adjuvant in Subjects With Mild to Moderate Alzheimer's Disease

JANSSEN Alzheimer Immunotherapy Research & Development, LLC1 site in 1 country126 target enrollmentJanuary 2011

ConditionsAlzheimer's Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Alzheimer's Disease
Sponsor: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Enrollment: 126
Locations: 1
Primary Endpoint: To evaluate the effect of ACC-001 in combination with an adjuvant immunostimulatory agent (QS-21), administered intramuscularly compared to placebo on cerebral amyloid burden in subjects with mild to moderate Alzheimer's disease.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A Phase II clinical research study to evaluate the efficacy and safety of two different dose levels of an injectable investigational treatment (ACC-001) in subjects with Mild-to-Moderate Alzheimer's disease. ACC-001 (vanutide cridificar) is a beta amyloid fragment attached to a carrier protein. It is intended to help induce an antibody response against beta amyloid and is administered as an intramuscular injection.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

February 2014

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 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, seizure or autoimmune disease
•History of myocardial infarction within the last 2 years
•Smoking greater than 20 cigarettes per day
•Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications (anticonvulsants used for non-seizure reasons are allowed)
•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

Outcomes

Primary Outcomes

To evaluate the effect of ACC-001 in combination with an adjuvant immunostimulatory agent (QS-21), administered intramuscularly compared to placebo on cerebral amyloid burden in subjects with mild to moderate Alzheimer's disease.

Time Frame: 24 Months

Secondary Outcomes

To evaluate the safety and tolerability of 2 dosage levels of ACC-001 plus QS-21 vs. placebo in subjects with mild to moderate AD.(24 Months)
Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in measurements of immunogenicity.(24 Months)
Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in disease biomarkers.(24 Months)
Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in cognitive and functional scales.(24 Months)
Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in health outcome measures.(24 Months)