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The primary goal of this study is to evaluate the effect of PF-04360365 on the clearance of ABETA from the CSF (cerebrospinal fluid) in patients with mild Alzheimer's disease and healthy volunteers. Additionally, the study will assess the pharmacokinetics of PF-04360365, pharmacokinetic and pharmacodynamic relationships in plasma and CSF and the safety and tolerability of single doses of PF-04360365 administered to patients with Alzheimer's disease and healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04360365 | Experimental |
| |
| Placebo | Placebo Comparator | single dose administered intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04360365 | Biological | 10 mg/kg, single dose administered intravenously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Fractional Clearance rate of ABeta peptide in CSF | 36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the ratio of CSF labeled/unlabeled ABETA time curve from onset of clearance to 36h following start of infusion | 36 hours | |
| PF-04360365 concentrations and ABETA concentrations in plasma and CSF | 36 hours |
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Inclusion Criteria:
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 | Glendale | California | 91206 | United States | ||
| 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 |
|
| Ratio of labeled/unlabeled leucine in plasma and CSF post labeled leucine administration | 36 hours |
| Adverse events, vital signs, clinical labs, electrocardiograms, physical / neurologic examinations, Columbia Suicide Severity Rating Scale, MRI | 6 months |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Pfizer Investigational Site | Stockholm | 141 86 | Sweden |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |