Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's Disease
NCT ID: NCT01369225
Last Updated: 2017-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2011-07-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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0.5 mg/kg AAB-003
AAB-003 (PF-05236812)
0.5 mg/kg AAB-003, IV
1 mg/kg AAB-003
AAB-003 (PF-05236812)
1 mg/kg AAB-003, IV
2 mg/kg AAB-003
AAB-003 (PF-05236812)
2 mg/kg AAB-003, IV
4 mg/kg AAB-003
AAB-003 (PF-05236812)
4 mg/kg AAB-003, IV
8 mg/kg AAB-003
AAB-003 (PF-05236812)
8 mg/kg AAB-003, IV
Interventions
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AAB-003 (PF-05236812)
0.5 mg/kg AAB-003, IV
AAB-003 (PF-05236812)
1 mg/kg AAB-003, IV
AAB-003 (PF-05236812)
2 mg/kg AAB-003, IV
AAB-003 (PF-05236812)
4 mg/kg AAB-003, IV
AAB-003 (PF-05236812)
8 mg/kg AAB-003, IV
Eligibility Criteria
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Inclusion Criteria
* MMSE 12 or greater
Exclusion Criteria
* Experienced SAE, vasogenic edema and/or intracranial hemorrhage in study B2601001
50 Years
90 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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MD Clinical
Hallandale, Florida, United States
Munroe Regional Medical Center
Ocala, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Trinity Care Solutions
Ocala, Florida, United States
Advanced Imaging of Ocala
Ocala, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Foers Medical Arts Pharmacy
Bethesda, Maryland, United States
CBH Health, LLC
Rockville, Maryland, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
Borgess Research Institute
Kalamazoo, Michigan, United States
KNI Southwest Michigan Imaging Center, LLC
Kalamazoo, Michigan, United States
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, United States
DePaul Health Center-MRI Department
St Louis, Missouri, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States
Central Jersey Radiology
Oakhurst, New Jersey, United States
Seoul National University Hospital, Department Neurology
Seongnam-si, Gyeonggi-do, South Korea
Inha University Hospital, Department of Neurology
Incheon, , South Korea
Samsung Medical Center, Department of Neurology
Seoul, , South Korea
Korea University Anam Hospital IRB
Seoul, , South Korea
ASAN Medical Center
Seoul, , South Korea
Konkuk University Medical Center, Department of Neurology
Seoul, , South Korea
Countries
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References
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Delnomdedieu M, Duvvuri S, Li DJ, Atassi N, Lu M, Brashear HR, Liu E, Ness S, Kupiec JW. First-In-Human safety and long-term exposure data for AAB-003 (PF-05236812) and biomarkers after intravenous infusions of escalating doses in patients with mild to moderate Alzheimer's disease. Alzheimers Res Ther. 2016 Mar 1;8(1):12. doi: 10.1186/s13195-016-0177-y.
Related Links
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Other Identifiers
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B2601003
Identifier Type: -
Identifier Source: org_study_id
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