A Phase I, Single Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease
A Phase 1, Randomized, Placebo-Controlled, Double Blind, Dose-Escalation, Multicenter Study Of The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Immunogenicity Of A Single Intravenous Dose Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease
1 other identifier
interventional
20
1 country
9
Brief Summary
The purpose of this study is to examine the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2008
Typical duration for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2008
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedDecember 7, 2010
December 1, 2010
2.7 years
January 22, 2008
December 6, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
To examine the safety and tolerability of a single dose of PF-04360365 in Japanese subjects with mild to moderate AD for one year following dosing.
1 year
Secondary Outcomes (1)
To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing.
1 year
Study Arms (6)
0.1 mg/kg
EXPERIMENTAL0.5 mg/kg
EXPERIMENTAL1 mg/kg
EXPERIMENTAL5 mg/kg
EXPERIMENTALPlacebo
PLACEBO COMPARATOR10 mg/kg
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Japanese male or females of non-childbearing potential, ages 50-85
- 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
You may not qualify if:
- Diagnosis or history of other dementia or neurodegenerative disorders
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (9)
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
Related Publications (1)
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.
PMID: 24131736DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 22, 2008
First Posted
February 5, 2008
Study Start
February 1, 2008
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
December 7, 2010
Record last verified: 2010-12