Multiple Intravenous Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease
Phase 1
Completed
- Conditions
- Alzheimer's Disease
- Interventions
- Biological: PF-04360365 8.5 mg/kgDrug: Placebo
- Registration Number
- NCT01125631
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-04360365 8.5 mg/kg PF-04360365 8.5 mg/kg - Placebo Placebo -
- Primary Outcome Measures
Name Time Method 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) 12 months Pharmacokinetics of PF-04360365 following administration of multiple doses in Japanese subjects with mild to moderate Alzheimer's disease. (plasma PF-04360365 concentrations) 12 months
- Secondary Outcome Measures
Name Time Method Plasma concentration of Aβ species following administration of multiple doses of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's disease. 12 months
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇯🇵Kanazawa, Ishikawa, Japan