Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
NCT ID: NCT00498602
Last Updated: 2016-01-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2007-11-30
2013-02-28
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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1
ACC-001
ACC-001 + QS-21
IM injection, ACC-001 (3ug, or 10ug, or 30ug) + QS-21 50ug at Day 1 and weeks 4, 12, 26, and 52
2
QS-21
QS-21
IM injection, QS-21 (50 ug) at Day 1 and weeks 4, 12, 26, and 52
3
Diluent: Phosphate Buffered Saline
Diluent: Phosphate Buffered Saline
IM injection, PBS Diluent at Day 1 and weeks 4, 12, 26, and 52
4
ACC-001
ACC-001
IM injection, ACC 001 (10 ug, 30ug) at Day 1 and weeks 4, 12, 26, and 52
Interventions
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ACC-001 + QS-21
IM injection, ACC-001 (3ug, or 10ug, or 30ug) + QS-21 50ug at Day 1 and weeks 4, 12, 26, and 52
QS-21
IM injection, QS-21 (50 ug) at Day 1 and weeks 4, 12, 26, and 52
Diluent: Phosphate Buffered Saline
IM injection, PBS Diluent at Day 1 and weeks 4, 12, 26, and 52
ACC-001
IM injection, ACC 001 (10 ug, 30ug) at Day 1 and weeks 4, 12, 26, and 52
Eligibility Criteria
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Inclusion Criteria
* Age 50-85
* Mini Mental State Examination (MMSE) 16-26 Other criteria apply
Exclusion Criteria
* Major psychiatric disorder
50 Years
85 Years
ALL
No
Sponsors
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JANSSEN Alzheimer Immunotherapy Research & Development, LLC
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Banner Alzheimer's Institute
Phoenix, Arizona, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
Banner Boswell Medical Center
Sun City, Arizona, United States
Sun Health Research Institute
Sun City, Arizona, United States
University of California - San Francisco
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
General Clinical Research Center
New Haven, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
General Clinical Research Center
Washington D.C., District of Columbia, United States
GUMC
Washington D.C., District of Columbia, United States
MD Clinical
Hallandale, Florida, United States
Palm Beach Neurology - Premiere Research Institute
West Palm Beach, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Barrnes-Jewish Hospital at Washington University
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States
Pharmcare USA
Edison, New Jersey, United States
Columbia Univ/Taub Institute Irving Ctr for Clinical Researc
New York, New York, United States
CUMC Research Pharmacy
New York, New York, United States
Butler Hospital
Providence, Rhode Island, United States
The Memory Clinic
Bennington, Vermont, United States
The Pharmacy
Bennington, Vermont, United States
Countries
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References
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Pasquier F, Sadowsky C, Holstein A, Leterme Gle P, Peng Y, Jackson N, Fox NC, Ketter N, Liu E, Ryan JM; ACC-001 (QS-21) Study Team. Two Phase 2 Multiple Ascending-Dose Studies of Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Mild-to-Moderate Alzheimer's Disease. J Alzheimers Dis. 2016;51(4):1131-43. doi: 10.3233/JAD-150376.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B2571005
Identifier Type: OTHER
Identifier Source: secondary_id
3134K1-2201
Identifier Type: -
Identifier Source: org_study_id
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