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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04360365 8.5 mg/kg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04360365 8.5 mg/kg | Biological | 8.5 mg/kg every 8 weeks (4 doses total) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Japanese males or females of non childbearing potential, age > or = 50
Diagnosis of probable Alzheimer's disease, consistent with criterial from both:
Mini-mental status exam score of 16-26 inclusive
Rosen-Modified Hachinski Ischemia Score of < or = 4
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Hirosaki | Aomori | Japan | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C572721 | ponezumab |
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| Placebo |
| Drug |
Placebo every 8 weeks (4 doses total) |
|
| Fukuoka |
| Fukuoka |
| Japan |
| Pfizer Investigational Site | Fukuyama | Hiroshima | Japan |
| Pfizer Investigational Site | Kanazawa | Ishikawa-ken | Japan |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |