Clinical trial NCT00607308: A Phase I, Single Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-02-05
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing.
timeFrame: 1 year
Other outcomes:
Locations:
city: Hirosaki
country: Japan
facility: Pfizer Investigational Site
state: Aomori
city: Fukuoka-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Fukuyama city
country: Japan
facility: Pfizer Investigational Site
state: Hiroshima
city: Tsukuba
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Niigata-shi
country: Japan
facility: Pfizer Investigational Site
state: Niigata
city: Bunkyo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Kodaira
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Kanazawa
country: Japan
facility: Pfizer Investigational Site
city: Kyoto
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.