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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Biological: PF-04360365
* Biological: PF-04360365
* Biological: PF-04360365
* Biological: PF-04360365
* Drug: Placebo
* Biological: PF-04360365


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.1 mg/kg<br> | Biological: PF-04360365<br>* Single dose of 0.1 mg/kg IV on Day 1<br>|
| Experimental: 0.5 mg/kg<br> | Biological: PF-04360365<br>* Single dose of 0.5 mg/kg IV on Day 1<br>|
| Experimental: 1 mg/kg<br> | Biological: PF-04360365<br>* Single dose of 1 mg/kg IV on Day 1<br>|
| Experimental: 5 mg/kg<br> | Biological: PF-04360365<br>* Single dose of 5 mg/kg IV on Day 1<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Single dose of placebo IV on Day 1<br>|
| Experimental: 10 mg/kg<br> | Biological: PF-04360365<br>* Single dose of 10 mg/kg IV on Day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing. |  | 1 year |