A Phase I, Single Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease

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NCT00607308

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Study Location
Pfizer Investigational Site
Hirosaki, Aomori, , Japan
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Contact
1-800-718-1021
[email protected]
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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase I, Single Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Biological: PF-04360365
    Single dose of 0.1 mg/kg IV on Day 1
  • Biological: PF-04360365
    Single dose of 0.5 mg/kg IV on Day 1
  • Biological: PF-04360365
    Single dose of 1 mg/kg IV on Day 1
  • Biological: PF-04360365
    Single dose of 5 mg/kg IV on Day 1
  • Drug: Placebo
    Single dose of placebo IV on Day 1
  • Biological: PF-04360365
    Single dose of 10 mg/kg IV on Day 1
Study Arms  ICMJE
  • Experimental: 0.1 mg/kg
    Intervention: Biological: PF-04360365
  • Experimental: 0.5 mg/kg
    Intervention: Biological: PF-04360365
  • Experimental: 1 mg/kg
    Intervention: Biological: PF-04360365
  • Experimental: 5 mg/kg
    Intervention: Biological: PF-04360365
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: 10 mg/kg
    Intervention: Biological: PF-04360365
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2009)		20
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2008)		16
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00607308
Other Study ID Numbers  ICMJE A9951005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP