Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease
NCT ID: NCT00722046
Last Updated: 2022-11-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
198 participants
INTERVENTIONAL
2008-12-05
2011-08-16
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
TRIPLE
Study Groups
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PF-04360365 0.1 mg/kg
PF-04360365 0.1 mg/kg
0.1 mg/kg every 60 days (10 doses total)
PF-04360365 0.5 mg/kg
PF-04360365 0.5 mg/kg
0.5 mg/kg every 60 days (10 doses total)
PF-04360365 1 mg/kg
PF-04360365 1 mg/kg
1 mg/kg every 60 days (10 doses total)
Placebo
Placebo
Placebo every 60 days (10 doses total)
PF-04360365 3 mg/kg
PF-04360365 3 mg/kg
3 mg/kg every 60 days (10 doses total)
PF-04360365 8.5 mg/kg
PF-04360365 8.5 mg/kg
8.5 mg/kg every 60 days (10 doses total)
Interventions
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PF-04360365 0.1 mg/kg
0.1 mg/kg every 60 days (10 doses total)
PF-04360365 0.5 mg/kg
0.5 mg/kg every 60 days (10 doses total)
PF-04360365 1 mg/kg
1 mg/kg every 60 days (10 doses total)
Placebo
Placebo every 60 days (10 doses total)
PF-04360365 3 mg/kg
3 mg/kg every 60 days (10 doses total)
PF-04360365 8.5 mg/kg
8.5 mg/kg every 60 days (10 doses total)
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of probable Alzheimer's disease, consistent with criterial from both:
* National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
* Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
* Mini-mental status exam score of 16-26 inclusive
* Rosen-Modified Hachinski Ischemia Score of \< or = 4
Exclusion Criteria
* Diagnosis or history of clinically significant cerebrovascular disease
* Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities
* History of autoimmune disorders
* History of allergic or anaphylactic reactions
50 Years
ALL
No
Sponsors
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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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Pivotal Research Center
Peoria, Arizona, United States
Sun Radiology- for MRI
Peoria, Arizona, United States
Dedicated Phase 1
Phoenix, Arizona, United States
Neuroscience Consultants, LLC
Miami, Florida, United States
Miami Research Associates
South Miami, Florida, United States
MRA Clinical Research
South Miami, Florida, United States
Sleep Florida, LLC
South Miami, Florida, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Alexian Brothers Neurosciences Institute
Elk Grove Village, Illinois, United States
Stark Pharmacy
Overland Park, Kansas, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Memory Enhancement Center of America, Inc
Eatontown, New Jersey, United States
Central Jersey Radiology
Oakhurst, New Jersey, United States
Butler Hospital
Providence, Rhode Island, United States
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Queen Elizabeth Hospital and Health Service
Woodville South, South Australia, Australia
Heidelberg Repatriation Hospital, Austin Health
Heidelberg West, Victoria, Australia
The McCusker Foundation for Alzheimer's Disease Research
Nedlands, Western Australia, Australia
ZNA Middelheim / Neurology
Antwerp, , Belgium
UZ Antwerpen, Department of Neurology
Edegem, , Belgium
UZ Brussel / Geriatrie
Jette, , Belgium
U.Z. Gasthuisberg / Neurologie
Leuven, , Belgium
University of British Columbia Hospital, Division of Neurology
Vancouver, British Columbia, Canada
Parkwood Hospital, Geriatric Medicine
London, Ontario, Canada
Kawartha Regional Memory Clinic
Peterborough, Ontario, Canada
Toronto Memory Program
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Recherche Clinique de Neurologie
Montreal, Quebec, Canada
Diex Recherche Inc.
Sherbrooke, Quebec, Canada
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Hanyang University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
The Pharmacy Department
Cheadle, Chesire, United Kingdom
The Shalbourne Suite
Swindon, Wiltshire, United Kingdom
Kingshill Research Centre
Swindon, Wiltshire, United Kingdom
MAC UK Neuroscience Ltd
Manchester, , United Kingdom
Wellcome Trust Clinical Research Facility
Southampton, , United Kingdom
Memory Assessment and Research Centre
Southampton, , United Kingdom
Countries
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Other Identifiers
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2008-000986-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MD IN AD PATIENT
Identifier Type: OTHER
Identifier Source: secondary_id
A9951002
Identifier Type: -
Identifier Source: org_study_id
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