NCT00607308
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- PF-04360365
- Conditions
- Alzheimer's Disease
- Sponsor
- Pfizer
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
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
Arms & Interventions
0.1 mg/kg
Intervention: PF-04360365
0.5 mg/kg
Intervention: PF-04360365
1 mg/kg
Intervention: PF-04360365
5 mg/kg
Intervention: PF-04360365
Placebo
Intervention: Placebo
10 mg/kg
Intervention: PF-04360365
Outcomes
Primary Outcomes
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 Outcomes
- To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing.(1 year)
Study Sites (1)
Loading locations...
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