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| Name | Class |
|---|---|
| Alltech Life Sciences Inc. | INDUSTRY |
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The purpose of this study is to evaluate if the use of a yeast-selenium supplement (AT-001) is safe in elderly subjects who do not have dementia, and further, to see if the supplement improves tests that are related to brain health.
Double blind, placebo-controlled, single-center study. Approximately 40 healthy volunteers will be randomized to the study drug and 20 healthy volunteers randomized to the placebo, for a total of 60 enrolled participants.
All participants will be treated with the study drug or placebo for 12 months. Subjects will be seen in the clinic for the following visits: Screening (Day -14), Baseline (Day 0), Month 6, and End-of-Study (Month 12) while on study drug. An additional safety visit at Month 13 (four weeks after study drug discontinuation) will be required of all participants.
Participants will undergo vital signs assessment, medical history review, medication list review, and review of Adverse Events (AEs) and Serious Adverse Events (SAEs) at each visit.
Participants will undergo neuropsychological testing and routine physical examinations at the screening, baseline, and end-of-study visits.
Participants will undergo blood draws, urine collection, MRI to assess lumbar puncture safety, and lumbar puncture at the baseline and end-of-study visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AT-001 | Experimental | Yeast-selenium supplement |
|
| Placebo | Placebo Comparator | Yeast supplement devoid of selenium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AT-001 | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebrospinal fluid Aβ42 | Baseline to End-of-Study (12 months) | |
| Serum levels of prostaglandins PGF2α and PGE2 | Baseline to End-of-Study (12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Urine levels of prostaglandins PGF2α and PGE2 | Baseline to End-of-Study (12 months) | |
| Cerebrospinal fluid levels of phosphorylated and total tau protein | Baseline to End-of-Study (12 months) | |
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Inclusion Criteria:
Exclusion Criteria:
Excluded Medications:
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| Name | Affiliation | Role |
|---|---|---|
| Richard R Murphy, MD | University of Kentucky | Principal Investigator |
| Ronan Powers, PhD | Alltech Life Sciences Inc. | Study Director |
| Gregory A. Jicha, MD, PhD | University of Kentucky | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Sanders-Brown Center on Aging Clinic | Lexington | Kentucky | 40504 | United States |
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| ID | Term |
|---|---|
| C000721147 | caficrestat |
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|
| Volumetric brain MRI measurements |
| Baseline to End-of-Study (12 months) |
| Neurocognitive measure: Free and Cued Selective Reminding Test (FCSRT) | Baseline to End-of-Study (12 months) |
| Neurocognitive measure: Trail-making test parts A and B | Baseline to End-of-Study (12 months) |
| Neurocognitive measure: Naming, both single letter fluency and animal naming. | Baseline to End-of-Study (12 months) |