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The primary purpose of this study is to assess biomarker known as amyloid beta peptide 40 (Ab40) in Cerebrospinal Fluid (CSF), following a single oral dose of PAZ-417 in subjects with Alzheimer Disease (AD). This study will also consider another biomarker amyloid beta peptide 42 (Ab42) in Cerebrospinal Fluid in subjects with Alzheimer Disease and assess the safety, tolerability and pharmacokinetic profile of PAZ-417 in both plasma and Cerebrospinal Fluid in these subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
| ||
| PAZ-417 |
| Measure | Description | Time Frame |
|---|---|---|
| This study is the measurement of a biomarker known as amyloid beta peptide 40 (Ab40) in Cerebrospinal Fluid (CSF), following a single oral dose of PAZ-417 in subjects with Alzheimer Disease (AD). | 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| To measure both amyloid beta peptide 42 (Ab42) and PAZ-417 in both plasma and CSF and assess safety using the results of physical examinations, vital sign measurements, ECGs, cardiac telemetry, standard laboratory tests and collection of AES. | 6 days |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Clinical Trials | Glendale | California | 91026 | United States |
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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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|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |