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Trial record 1 of 8 for:    PF-04360365
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Multiple Intravenous Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT01125631
Recruitment Status : Completed
First Posted : May 18, 2010
Last Update Posted : August 12, 2011
Sponsor:
Information provided by:

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  (Clinical Trial)
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 2010
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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)


Outcome Measures

Primary Outcome Measures :
  1. 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) [ Time Frame: 12 months ]
  2. Pharmacokinetics of PF-04360365 following administration of multiple doses in Japanese subjects with mild to moderate Alzheimer's disease. (plasma PF-04360365 concentrations) [ Time Frame: 12 months ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125631


Locations
Japan
Pfizer Investigational Site
Hirosaki, Aomori, Japan
Pfizer Investigational Site
Fukuoka-shi, Fukuoka, Japan
Pfizer Investigational Site
Fukuyama city, Hiroshima, Japan
Pfizer Investigational Site
Kanazawa, Ishikawa, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01125631     History of Changes
Other Study ID Numbers: A9951016
First Posted: May 18, 2010    Key Record Dates
Last Update Posted: August 12, 2011
Last Verified: August 2011

Keywords provided by Pfizer:
Alzheimer's disease
amyloid
antibody
Japanese

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders