Multiple Intravenous Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

A Phase 1, Randomized, Placebo-Controlled, Double Blind, Multicenter Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenous Doses Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125631
• Other study ID #: A9951016
• Status: Completed
• Phase: Phase 1
• First received: May 17, 2010
• Last updated: August 11, 2011
• Start date: May 2010
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to examine the safety and tolerability of a multiple dose of PF-04360365 administered over approximately 10 minutes in Japanese patients with mild-to-moderate Alzheimer's disease and to characterize the pharmacokinetics of PF-04360365 following administration of multiple doses in Japanese patients with mild-to-moderate Alzheimer's disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Japanese males or females of non childbearing potential, age > or = 50

• Diagnosis of probable Alzheimer's disease, consistent with criterial from both:

• National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)

• Diagnostic and Statistical Manual of Mental Disorders (DSM IV)

• Mini-mental status exam score of 16-26 inclusive

• Rosen-Modified Hachinski Ischemia Score of < or = 4

Exclusion Criteria:

• Diagnosis or history of other demential 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Biological:
• PF-04360365 8.5 mg/kg
8.5 mg/kg every 8 weeks (4 doses total)

Drug:
• Placebo
Placebo every 8 weeks (4 doses total)

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Fukuoka-shi	Fukuoka
Japan	Pfizer Investigational Site	Fukuyama city	Hiroshima
Japan	Pfizer Investigational Site	Hirosaki	Aomori
Japan	Pfizer Investigational Site	Kanazawa	Ishikawa

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's disease dosed for 6 months. (adverse events, physical/neurologic exams, vital signs, 12-lead ECG, clinical labs, brain MRI, immunogenicity and cognitive assessments)		12 months	No
Primary	Pharmacokinetics of PF-04360365 following administration of multiple doses in Japanese subjects with mild to moderate Alzheimer's disease. (plasma PF-04360365 concentrations)		12 months	No
Secondary	Plasma concentration of Aß species following administration of multiple doses of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's disease.		12 months	No

External Links

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