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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Alzheimer's Disease

Treatments

Drug: Placebo

Biological: PF-04360365

Study type

Interventional

Funder types

Industry

Identifiers

NCT00607308

A9951005

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

50 to 85 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

20 participants in 6 patient groups, including a placebo group

0.1 mg/kg

Experimental group

Treatment:

Biological: PF-04360365

0.5 mg/kg

Experimental group

Treatment:

Biological: PF-04360365

1 mg/kg

Experimental group

Treatment:

Biological: PF-04360365

5 mg/kg

Experimental group

Treatment:

Biological: PF-04360365

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

10 mg/kg

Experimental group

Treatment:

Biological: PF-04360365

Trial contacts and locations

9

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