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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
PF-04360365
PF-04360365
PF-04360365
PF-04360365
Placebo
PF-04360365
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

0.1 mg/kg

0.5 mg/kg

1 mg/kg

5 mg/kg

Placebo

10 mg/kg

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing.

Full Information

First Posted
January 22, 2008
Last Updated
December 6, 2010
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00607308
Brief Title
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

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.1 mg/kg
Arm Type
Experimental
Arm Title
0.5 mg/kg
Arm Type
Experimental
Arm Title
1 mg/kg
Arm Type
Experimental
Arm Title
5 mg/kg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
10 mg/kg
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
PF-04360365
Intervention Description
Single dose of 0.1 mg/kg IV on Day 1
Intervention Type
Biological
Intervention Name(s)
PF-04360365
Intervention Description
Single dose of 0.5 mg/kg IV on Day 1
Intervention Type
Biological
Intervention Name(s)
PF-04360365
Intervention Description
Single dose of 1 mg/kg IV on Day 1
Intervention Type
Biological
Intervention Name(s)
PF-04360365
Intervention Description
Single dose of 5 mg/kg IV on Day 1
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single dose of placebo IV on Day 1
Intervention Type
Biological
Intervention Name(s)
PF-04360365
Intervention Description
Single dose of 10 mg/kg IV on Day 1
Primary Outcome Measure Information:
Title
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Hirosaki
State/Province
Aomori
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuyama city
State/Province
Hiroshima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tsukuba
State/Province
Ibaraki
Country
Japan
Facility Name
Pfizer Investigational Site
City
Niigata-shi
State/Province
Niigata
Country
Japan
Facility Name
Pfizer Investigational Site
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kodaira
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kanazawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kyoto
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24131736
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9951005&StudyName=A%20Phase%20I%2C%20Single%20Dose%20Study%20Of%20PF-04360365%20In%20Japanese%20Patients%20With%20Mild%20To%20Moderate%20Alzheimer%27s%20Disease%20
Description
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A Phase I, Single Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease

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