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COMPLETEDPHASE1

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

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

NCT00607308•Pfizer

View on ClinicalTrials.gov

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

Age

50 - 85 years

Sex

ALL

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

Locations (9)

Pfizer Investigational Site

Hirosaki, Aomori, Japan

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Pfizer Investigational Site

Fukuyama, Hiroshima, Japan

Pfizer Investigational Site

Tsukuba, Ibaraki, Japan

Pfizer Investigational Site

Kanazawa, Kanazawa, Japan

Pfizer Investigational Site

Kyoto, Kyoto, Japan

Pfizer Investigational Site

Niigata, Niigata, Japan

Pfizer Investigational Site

Bunkyo-ku, Tokyo, Japan

Pfizer Investigational Site

Kodaira, Tokyo, Japan

Key Dates

Start Date

February 1, 2008

Primary Completion Date

October 1, 2010

Completion Date

October 1, 2010

Last Updated

December 7, 2010

Enrollment

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

PF-04360365

BIOLOGICAL

PF-04360365

BIOLOGICAL

PF-04360365

BIOLOGICAL

PF-04360365

BIOLOGICAL

Placebo

DRUG

PF-04360365

BIOLOGICAL

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 7, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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