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

Purpose

Examine the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of PF-04360365 in Japanese subjects with mild to moderate AD

Condition	Intervention	Phase
Alzheimer's Disease	Biological: PF-04360365 Drug: Placebo	Phase I

Genetics Home Reference related topics:

Alzheimer disease

MedlinePlus related topics:

Alzheimer's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study

Official Title:	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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	16
Study Start Date:	March 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
0.1 mg/kg: Experimental	Biological: PF-04360365 Single dose of 0.1 mg/kg IV on Day 1
0.5 mg/kg: Experimental	Biological: PF-04360365 Single dose of 0.5 mg/kg IV on Day 1
1 mg/kg: Experimental	Biological: PF-04360365 Single dose of 1 mg/kg IV on Day 1
5 mg/kg: Experimental	Biological: PF-04360365 Single dose of 5 mg/kg IV on Day 1
Placebo: Placebo Comparator	Drug: Placebo Single dose of placebo IV on Day 1

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607308

Contacts


Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations


Japan
	Pfizer Investigational Site	Recruiting
	Kanazawa, Japan
	Pfizer Investigational Site	Not yet recruiting
	Kyoto, Japan

Japan, Aomori
	Pfizer Investigational Site	Not yet recruiting
	Hirosaki, Aomori, Japan

Japan, Fukuoka
	Pfizer Investigational Site	Recruiting
	Fukuoka-shi, Fukuoka, Japan

Japan, Ibaraki
	Pfizer Investigational Site	Not yet recruiting
	Tsukuba, Ibaraki, Japan

Japan, Niigata
	Pfizer Investigational Site	Recruiting
	Niigata-shi, Niigata, Japan

Japan, TOKYO
	Pfizer Investigational Site	Recruiting
	Bunkyo-ku, TOKYO, Japan

Japan, Tokyo
	Pfizer Investigational Site	Not yet recruiting
	Kodaira, Tokyo, Japan

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A9951005
First Received:	January 22, 2008
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00607308
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders

Mental Disorders

Alzheimer Disease

Central Nervous System Diseases

Neurodegenerative Diseases

Brain Diseases

Dementia

Cognition Disorders

Delirium

Additional relevant MeSH terms:

Nervous System Diseases

Tauopathies

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00607308