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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01125631

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Biological: PF-04360365 8.5 mg/kg Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PF-04360365 8.5 mg/kg	Biological: PF-04360365 8.5 mg/kg 8.5 mg/kg every 8 weeks (4 doses total)
Placebo Comparator: Placebo	Drug: Placebo Placebo every 8 weeks (4 doses total)

Arm

Intervention/Treatment

Experimental: PF-04360365 8.5 mg/kg

Biological: PF-04360365 8.5 mg/kg

8.5 mg/kg every 8 weeks (4 doses total)

Placebo Comparator: Placebo

Drug: Placebo

Placebo every 8 weeks (4 doses total)

Outcome Measures

Primary Outcome Measures

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]
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]

Secondary Outcome Measures

Plasma concentration of Aβ species following administration of multiple doses of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's disease. [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Pfizer Investigational Site	Hirosaki	Aomori	Japan
2	Pfizer Investigational Site	Fukuoka-shi	Fukuoka	Japan
3	Pfizer Investigational Site	Fukuyama city	Hiroshima	Japan
4	Pfizer Investigational Site	Kanazawa	Ishikawa	Japan