Study Evaluating The Safety Of AAB-003 (PF-05236812) In Subjects With Alzheimer's Disease
NCT ID: NCT01193608
Last Updated: 2017-02-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
88 participants
INTERVENTIONAL
2010-09-30
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
QUADRUPLE
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
Placebo
Placebo
Placebo, 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
Placebo
Placebo, IV
Eligibility Criteria
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Inclusion Criteria
* Concurrent use of cholinesterase inhibitor or memantine allowed, if stable.
* Caregiver will participate and be able to attend clinic visits with patient
Exclusion Criteria
* Major psychiatric disorder
* Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)
* Women of childbearing potential
50 Years
89 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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Early Phase Investigational Center
Escondido, California, United States
Synergy Clinical Research Center of Escondido
Escondido, California, United States
MD Clinical
Hallandale, Florida, United States
Franck's Pharmacy
Ocala, Florida, United States
Munroe Regional Medical Center
Ocala, Florida, United States
Renstar Medical Research
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
Brentwood Behavioral Healthcare
Flowood, Mississippi, United States
Marty's Pharmacy
Flowood, Mississippi, United States
Precise Research Centers
Flowood, Mississippi, United States
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, United States
DePaul Health Center
St Louis, Missouri, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States
Pharmacare USA
Edison, New Jersey, United States
Central Jersey Radiology
Oakhurst, New Jersey, United States
Belmont Center for Comprehensive Treatment
Philadelphia, Pennsylvania, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
Seoul National University Bundang Hospital, Department of 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
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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3245K1-1000
Identifier Type: OTHER
Identifier Source: secondary_id
B2601001
Identifier Type: -
Identifier Source: org_study_id
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