A Phase I, Single Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease
NCT ID: NCT00607308
Last Updated: 2010-12-07
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
PHASE1
20 participants
INTERVENTIONAL
2008-02-29
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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0.1 mg/kg
PF-04360365
Single dose of 0.1 mg/kg IV on Day 1
0.5 mg/kg
PF-04360365
Single dose of 0.5 mg/kg IV on Day 1
1 mg/kg
PF-04360365
Single dose of 1 mg/kg IV on Day 1
5 mg/kg
PF-04360365
Single dose of 5 mg/kg IV on Day 1
Placebo
Placebo
Single dose of placebo IV on Day 1
10 mg/kg
PF-04360365
Single dose of 10 mg/kg IV on Day 1
Interventions
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PF-04360365
Single dose of 0.1 mg/kg IV on Day 1
PF-04360365
Single dose of 0.5 mg/kg IV on Day 1
PF-04360365
Single dose of 1 mg/kg IV on Day 1
PF-04360365
Single dose of 5 mg/kg IV on Day 1
Placebo
Single dose of placebo IV on Day 1
PF-04360365
Single dose of 10 mg/kg IV on Day 1
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of probable Alzheimer's disease, consistent with criteria from both: (1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) 2) Text Revision of The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR)
* Mini-Mental Status Exam score of 16-26 inclusive
* Rosen-Modified Hachinski Ischemia score \< 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
85 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Hirosaki, Aomori, Japan
Pfizer Investigational Site
Fukuoka, Fukuoka, Japan
Pfizer Investigational Site
Fukuyama, Hiroshima, Japan
Pfizer Investigational Site
Tsukuba, Ibaraki, Japan
Pfizer Investigational Site
Kanazawa, Kanazawa, Japan
Pfizer Investigational Site
Kyoto, Kyoto, Japan
Pfizer Investigational Site
Niigata, Niigata, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Kodaira, Tokyo, Japan
Countries
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References
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Miyoshi I, Fujimoto Y, Yamada M, Abe S, Zhao Q, Cronenberger C, Togo K, Ishibashi T, Bednar MM, Kupiec JW, Binneman B. Safety and pharmacokinetics of PF-04360365 following a single-dose intravenous infusion in Japanese subjects with mild-to-moderate Alzheimer's disease: a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study. Int J Clin Pharmacol Ther. 2013 Dec;51(12):911-23. doi: 10.5414/CP201816.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A9951005
Identifier Type: -
Identifier Source: org_study_id