Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to examine the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's Disease.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.1 mg/kg | Experimental |
| |
| 0.5 mg/kg | Experimental |
| |
| 1 mg/kg | Experimental |
| |
| 5 mg/kg | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| 10 mg/kg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04360365 | Biological | Single dose of 0.1 mg/kg IV on Day 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To examine the safety and tolerability of a single dose of PF-04360365 in Japanese subjects with mild to moderate AD for one year following dosing. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing. | 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24131736 | Derived | Miyoshi I, Fujimoto Y, Yamada M, Abe S, Zhao Q, Cronenberger C, Togo K, Ishibashi T, Bednar MM, Kupiec JW, Binneman B. Safety and pharmacokinetics of PF-04360365 following a single-dose intravenous infusion in Japanese subjects with mild-to-moderate Alzheimer's disease: a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study. Int J Clin Pharmacol Ther. 2013 Dec;51(12):911-23. doi: 10.5414/CP201816. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PF-04360365 |
| Biological |
Single dose of 0.5 mg/kg IV on Day 1 |
|
| PF-04360365 | Biological | Single dose of 1 mg/kg IV on Day 1 |
|
| PF-04360365 | Biological | Single dose of 5 mg/kg IV on Day 1 |
|
| Placebo | Drug | Single dose of placebo IV on Day 1 |
|
| PF-04360365 | Biological | Single dose of 10 mg/kg IV on Day 1 |
|
| Fukuoka |
| Fukuoka |
| Japan |
| Pfizer Investigational Site | Fukuyama | Hiroshima | Japan |
| Pfizer Investigational Site | Tsukuba | Ibaraki | Japan |
| Pfizer Investigational Site | Kanazawa | Kanazawa | Japan |
| Pfizer Investigational Site | Kyoto | Kyoto | Japan |
| Pfizer Investigational Site | Niigata | Niigata | Japan |
| Pfizer Investigational Site | Bunkyo-ku | Tokyo | Japan |
| Pfizer Investigational Site | Kodaira | Tokyo | Japan |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C572721 | ponezumab |
Not provided
Not provided
Not provided