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This is a first-in-humans study of GSI-136, a drug being developed for the treatment of Alzheimer Disease. The main purpose of this study is to determine whether GSI-136 is safe and tolerable in healthy young and healthy elderly subjects. The amount of drug in the body and the effects of the drug on the body will also be evaluated at certain timepoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Subject on active drug |
|
| 2 | Placebo Comparator | Subject on placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSI-136 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of GSI-136 as evaluated from reported adverse events, scheduled physical examinations, vital sign measurements, orthostatic vital sign measurements, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics as evaluated from the blood and urine concentrations of GSI-136; Pharmacodynamics as evaluated from the levels of select biomarkers in the blood and the administration of a visual analog scale to measure sedation effects. | 6 months |
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York | New York | 10019 | 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 |