Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Mild to Moderate Alzheimer's Disease
NCT ID: NCT01284387
Last Updated: 2015-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
126 participants
INTERVENTIONAL
2011-01-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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3 μg ACC-001 / QS-21 50 μg IM dose 1
3 μg ACC-001 / QS-21 50 μg IM
ACC-001 (vanutide cridificar)
Comparisons of 2 different doses of ACC-001 or placebo for 24 months
10 μg ACC-001 / QS-21 50 μg IM dose 2
10 μg ACC-001 / QS-21 50 μg IM
ACC-001 (vanutide cridificar)
Comparisons of 2 different doses of ACC-001 or placebo for 24 months
Placebo - Phosphate buffered saline (PBS) IM dose
Placebo - Phosphate buffered saline (PBS) IM
No interventions assigned to this group
Interventions
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ACC-001 (vanutide cridificar)
Comparisons of 2 different doses of ACC-001 or placebo for 24 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
89 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
INDUSTRY
Responsible Party
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Locations
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Janssen AI Investigational Site
Sun City, Arizona, United States
Janssen AI Investigational Site
La Jolla, California, United States
Janssen AI Investigational Site
Long Beach, California, United States
Janssen AI Investigational Site
Los Angeles, California, United States
Janssen AI Investigational Site
Oxnard, California, United States
Janssen AI Investigational Site
San Diego, California, United States
Janssen AI Investigational Site
San Francisco, California, United States
Janssen AI Investigational Site
Washington D.C., District of Columbia, United States
Janssen AI Investigational Site
Miami, Florida, United States
Janssen AI Investigational Site
Miami, Florida, United States
Janssen AI Investigational Site
Ocala, Florida, United States
Janssen AI Investigational Site
Orlando, Florida, United States
Janssen AI Investigational Site
Sunrise, Florida, United States
Janssen AI Investigational Site
Tampa, Florida, United States
Janssen AI Investigational Site
Tampa, Florida, United States
Janssen AI Investigational Site
West Palm Beach, Florida, United States
Janssen AI Investigational Site
Scarborough, Maine, United States
Janssen AI Investigational Site
Boston, Massachusetts, United States
Janssen AI Investigational Site
Kansas City, Missouri, United States
Janssen AI Investigational Site
Las Vegas, Nevada, United States
Janssen AI Investigational Site
Princeton, New Jersey, United States
Janssen AI Investigational Site
Albany, New York, United States
Janssen AI Investigational Site
New York, New York, United States
Janssen AI Investigational Site
Centerville, Ohio, United States
Janssen AI Investigational Site
Oklahoma City, Oklahoma, United States
Countries
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References
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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.
Other Identifiers
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ACC-001-ALZ-2001
Identifier Type: -
Identifier Source: org_study_id
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