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

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ClinicalTrials.gov Identifier: NCT01284387

Recruitment Status : Completed

First Posted : January 27, 2011

Last Update Posted : January 5, 2015

Sponsor:

Collaborator:

Pfizer

Information provided by (Responsible Party):

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Study Description

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.

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	126 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, 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
Study Start Date :	January 2011
Actual Primary Completion Date :	January 2014
Actual Study Completion Date :	February 2014

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Amyloidosis

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Arms and Interventions

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 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

Outcome Measures

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 ]

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 ]
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 ]
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 ]
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 ]
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 ]

Eligibility Criteria

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Ages Eligible for Study:	50 Years to 89 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284387

Locations

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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier:	NCT01284387 History of Changes
Other Study ID Numbers:	ACC-001-ALZ-2001
First Posted:	January 27, 2011 Key Record Dates
Last Update Posted:	January 5, 2015
Last Verified:	December 2014

Keywords provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:


Mild to moderate Alzheimer's disease immunization amyloid imaging injection vaccine

Additional relevant MeSH terms:

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Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases	Neurocognitive Disorders Mental Disorders Saponin QA-21V1 Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs

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