Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Mild to Moderate Alzheimer's Disease (ACCTION)

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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Biological: ACC-001 (vanutide cridificar)

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Sun City, Arizona, United States, 33613
      • Janssen AI Investigational Site
  • California
    • La Jolla, California, United States, 92093
      • Janssen AI Investigational Site
    • Long Beach, California, United States, 90806
      • Janssen AI Investigational Site
    • Los Angeles, California, United States, 90095
      • Janssen AI Investigational Site
    • Oxnard, California, United States, 93030
      • Janssen AI Investigational Site
    • San Diego, California, United States, 92103
      • Janssen AI Investigational Site
    • San Francisco, California, United States, 94143
      • Janssen AI Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20057
      • Janssen AI Investigational Site
  • Florida
    • Miami, Florida, United States, 33137
      • Janssen AI Investigational Site
    • Miami, Florida, United States, 33410
      • Janssen AI Investigational Site
    • Ocala, Florida, United States, 34471
      • Janssen AI Investigational Site
    • Orlando, Florida, United States, 32806
      • Janssen AI Investigational Site
    • Sunrise, Florida, United States, 33351
      • Janssen AI Investigational Site
    • Tampa, Florida, United States, 33609
      • Janssen AI Investigational Site
    • Tampa, Florida, United States, 33617
      • Janssen AI Investigational Site
    • West Palm Beach, Florida, United States, 33407
      • Janssen AI Investigational Site
  • Maine
    • Scarborough, Maine, United States, 04074
      • Janssen AI Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Janssen AI Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Janssen AI Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Janssen AI Investigational Site
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Janssen AI Investigational Site
  • New York
    • Albany, New York, United States, 12205
      • Janssen AI Investigational Site
    • New York, New York, United States, 10032
      • Janssen AI Investigational Site
  • Ohio
    • Centerville, Ohio, United States, 45459
      • Janssen AI Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Janssen AI Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3 μg ACC-001 / QS-21 50 μg IM dose 1; 3 μg ACC-001 / QS-21 50 μg IM	Biological: ACC-001 (vanutide cridificar); Comparisons of 2 different doses of ACC-001 or placebo for 24 months; Other Names: vanutide cridificar
Experimental: 10 μg ACC-001 / QS-21 50 μg IM dose 2; 10 μg ACC-001 / QS-21 50 μg IM	Biological: ACC-001 (vanutide cridificar); Comparisons of 2 different doses of ACC-001 or placebo for 24 months; Other Names: vanutide cridificar
No Intervention: Placebo - Phosphate buffered saline (PBS) IM dose; Placebo - Phosphate buffered saline (PBS) IM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	As assessed by: The incidence and severity of treatment-emergent adverse events (TEAEs); and; Clinically important changes in safety assessment results (vital signs, weight, clinical laboratory tests, electrocardiograms [ECGs], brain magnetic resonance imaging [MRIs], and physical and neurological examinations).	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 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 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

Collaborators and Investigators

• Sponsor: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
• Collaborators: Pfizer

Publications and helpful links

General Publications

• Ketter N, Liu E, Di J, Honig LS, Lu M, Novak G, Werth J, LePrince Leterme G, Shadman A, Brashear HR. A Randomized, Double-Blind, Phase 2 Study of the Effects of the Vaccine Vanutide Cridificar with QS-21 Adjuvant on Immunogenicity, Safety and Amyloid Imaging in Patients with Mild to Moderate Alzheimer's Disease. J Prev Alzheimers Dis. 2016;3(4):192-201. doi: 10.14283/jpad.2016.118.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: January 20, 2011
• First Submitted That Met QC Criteria: January 25, 2011
• First Posted (Estimate): January 27, 2011

Study Record Updates

• Last Update Posted (Estimate): January 5, 2015
• Last Update Submitted That Met QC Criteria: December 11, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: vaccine; immunization; injection; Mild to moderate Alzheimer's disease; amyloid imaging
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: ACC-001-ALZ-2001