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This study will investigate the ability of ST101 to improve memory in people with Alzheimer's disease. This study also will examine the safety and tolerability of the drug. This study is evaluating 3 different dose levels of ST101 and placebo. Patients will have a 1 in 4 chance of getting placebo.
Alzheimer's disease (AD) is a progressive and fatal neurological illness. It produces changes in the brain that include loss of cells and accumulation of abnormal protein deposits. Initial symptoms are cognitive, with deficiencies in short-term memory the most common symptom. As the disease progresses so does the severity of cognitive deficiency. Loss of speech and immobility occur in the terminal stages There is no cure for AD and no marketed treatment that modifies the underlying disease process. Available therapies improve some symptoms of AD by increasing brain concentrations of molecules involved in cognition. ST101 differs from marketed therapies in that it has demonstrated two actions in animal research testing. It improves cognition and it also reduces the accumulation of abnormal protein deposits in the brain. These two properties suggest that ST101 may be a promising agent for the treatment of AD. This study is designed as a preliminary dose exploration/proof-of-concept investigation of the ability of ST101 to improve cognition during 12 weeks of administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 30 mg ST101 |
|
| 2 | Experimental | 90 mg ST101 |
|
| 3 | Experimental | 180 mg ST101 |
|
| 4 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ST101 | Drug | 30 mg; administered once/day |
| |
| ST101 |
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog) | Baseline, 4 weeks, 8 weeks,12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) | Baseline, 4 weeks, 8 weeks, 12 weeks | |
| Neuropsychiatric Inventory (NPI) | Baseline, 4 weeks, 8 weeks, 12 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Costa Mesa | California | United States | ||||
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| Drug |
90 mg; administered once/day |
|
| ST101 | Drug | 180 mg; administered once/day |
|
| Placebo | Drug | placebo to match ST101 tablets |
|
| Alzheimer's Disease Cooperative Study- Clinical Global Impression (ADCS-CGI) |
| Baseline (severity); 4 weeks, 8 weeks, 12 weeks (change) |
| Redlands |
| California |
| United States |
| San Diego | California | United States |
| Walnut Creek | California | United States |
| Deerfield Beach | Florida | United States |
| Delray Beach | Florida | United States |
| Orlando | Florida | United States |
| West Palm Beach | Florida | United States |
| Indianapolis | Indiana | United States |
| Shreveport | Louisiana | United States |
| Durham | North Carolina | United States |
| Toledo | Ohio | United States |
| Jenkinton | Pennsylvania | United States |
| Wichita Falls | Texas | United States |
| Bennington | Vermont | United States |
| Peterborough | Ontario | Canada |
| Toronto | Ontario | Canada |
| Montreal | Quebec | Canada |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
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