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

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

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

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:	20
Study Start Date:	February 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
10 mg/kg: Experimental	Biological: PF-04360365 Single dose of 10 mg/kg 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	Recruiting
Kyoto, Japan
Japan, Aomori
Pfizer Investigational Site	Active, not recruiting
Hirosaki, Aomori, Japan
Japan, Fukuoka
Pfizer Investigational Site	Recruiting
Fukuoka-shi, Fukuoka, Japan
Japan, Hiroshima
Pfizer Investigational Site	Active, not recruiting
Fukuyama city, Hiroshima, Japan
Japan, Ibaraki
Pfizer Investigational Site	Active, not 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	Active, not recruiting
Kodaira, Tokyo, Japan

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A9951005
Study First Received:	January 22, 2008
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00607308 History of Changes
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:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on September 03, 2009