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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00455000

Purpose

The purpose of this study is determine whether a single IV dose of PF-04360365 is safe and well tolerated in Adults with Mild to Moderate Alzheimer's disease.

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

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study
Official Title:	A Phase I, Randomized, Placebo Controlled, Double Blind Dose Escalation Study Of The Safety, Tolerability, Pharmacokinetics,Pharmacodynamics, And Immunogenicity Of A Single Intravenous Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease

Further study details as provided by Pfizer:

Primary Outcome Measures:

To examine the safety, tolerability, and pharmacokinetics of a single dose of PF-04360365 in subjects with mild to moderate AD for one year following dosing. [ Time Frame: 366 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing. [ Time Frame: 366 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	March 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active treatment: Experimental 5 possible active doses	Biological: PF-04360365 Monoclonal antibody
Placebo: Placebo Comparator	Drug: Placebo Placebo

Eligibility

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

Criteria

Inclusion Criteria:

Male or Females of non-childbearing potential, age 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); and 2)Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
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: NCT00455000

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

Australia, Victoria
Pfizer Investigational Site	Active, not recruiting
Heidelberg West, Victoria, Australia, 3081
Australia, Western Australia
Pfizer Investigational Site	Active, not recruiting
Nedlands, Western Australia, Australia, 6009
Pfizer Investigational Site	Active, not recruiting
Fremantle, Western Australia, Australia, 6160
Canada, Ontario
Pfizer Investigational Site	Recruiting
Toronto, Ontario, Canada, M3B 2W7
Pfizer Investigational Site	Recruiting
London, Ontario, Canada, N6C 5J1
Pfizer Investigational Site	Recruiting
London, Ontario, Canada, N6A 4G5
Pfizer Investigational Site	Recruiting
Toronto, Ontario, Canada, M5V 2T3
Pfizer Investigational Site	Recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Pfizer Investigational Site	Recruiting
Montreal, Quebec, Canada, H1T 2M4
Sweden
Pfizer Investigational Site	Active, not recruiting
Stockholm, Sweden, 141 86
United Kingdom
Pfizer Investigational Site	Active, not recruiting
Southampton, United Kingdom, SO16 6YD
Pfizer Investigational Site	Active, not recruiting
Southampton, United Kingdom, SO30 3JB

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:	A9951001
Study First Received:	March 29, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00455000
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

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

Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Immunoglobulins
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 16, 2009