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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01284387
First received: January 20, 2011
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Biological: ACC-001 (vanutide cridificar)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]

    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).

  • Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in disease biomarkers. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in measurements of immunogenicity. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in cognitive and functional scales. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in health outcome measures. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: January 2011
Study Completion Date: February 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: vanutide cridificar
No Intervention: Placebo - Phosphate buffered saline (PBS) IM dose
Placebo - Phosphate buffered saline (PBS) IM

  Eligibility

Ages Eligible for Study:   50 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284387

Locations
United States, Arizona
Janssen AI Investigational Site
Sun City, Arizona, United States, 33613
United States, California
Janssen AI Investigational Site
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
United States, District of Columbia
Janssen AI Investigational Site
Washington, District of Columbia, United States, 20057
United States, Florida
Janssen AI Investigational Site
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
United States, Maine
Janssen AI Investigational Site
Scarborough, Maine, United States, 04074
United States, Massachusetts
Janssen AI Investigational Site
Boston, Massachusetts, United States, 02115
United States, Missouri
Janssen AI Investigational Site
Kansas City, Missouri, United States, 64111
United States, Nevada
Janssen AI Investigational Site
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Janssen AI Investigational Site
Princeton, New Jersey, United States, 08540
United States, New York
Janssen AI Investigational Site
Albany, New York, United States, 12205
Janssen AI Investigational Site
New York, New York, United States, 10032
United States, Ohio
Janssen AI Investigational Site
Centerville, Ohio, United States, 45459
United States, Oklahoma
Janssen AI Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Sponsors and Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer
  More Information

No publications provided

Responsible Party: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01284387     History of Changes
Other Study ID Numbers: ACC-001-ALZ-2001
Study First Received: January 20, 2011
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:
Mild to moderate Alzheimer's disease
immunization
amyloid imaging
injection
vaccine

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
QS 21
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014