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This is a safety and tolerability study investigating the effect of HPP854 in subjects with mild cognitive impairment or a diagnosis of mild Alzheimer's disease. The study will assess the pharmacokinetic and pharmacodynamic relationships of HPP854 in plasma, pharmacodynamic relationship in cerebral spinal fluid and plasma concentration profiles for Amyloid-Beta.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPP854 | Experimental | Oral HPP854 once a day for 28 days. |
|
| Placebo | Placebo Comparator | Oral, placebo once a day for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPP854 | Drug | Oral, once a day for 28 days. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participant Adverse Events | Day 1 to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of participant plasma HPP854 concentrations | Day 1 to Day 30 | |
| Change in cerebrospinal fluid concentration of Amyloid-Beta | Day -6 to Day 35 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Hernandez, Ph.D. | High Point Pharmaceuticals, LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elite Research Institute | Miami | Florida | 33169 | United States | ||
| Duke Clinical Research Unit |
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| Drug |
Oral, once a day for 28 days. |
|
| Durham |
| North Carolina |
| 27710 |
| United States |
| High Point Clinical Trials Center | High Point | North Carolina | 27265 | United States |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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