Clinical trial NCT01125631: Multiple Intravenous Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
amyloid
antibody
Japanese
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-05-18
Enrollment: 8
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: 12 months
measure: Pharmacokinetics of PF-04360365 following administration of multiple doses in Japanese subjects with mild to moderate Alzheimer's disease. (plasma PF-04360365 concentrations)
timeFrame: 12 months
Secondary outcomes:
measure: Plasma concentration of Aβ species following administration of multiple doses of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's disease.
timeFrame: 12 months
Other outcomes:
Locations:
city: Hirosaki
country: Japan
facility: Pfizer Investigational Site
state: Aomori
city: Fukuoka-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Fukuyama city
country: Japan
facility: Pfizer Investigational Site
state: Hiroshima
city: Kanazawa
country: Japan
facility: Pfizer Investigational Site
state: Ishikawa
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: