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NCT01731093 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of Antioxidant (AT-001)for Reducing Brain Oxidative Stress
A Phase 1 study of Oxidative Stress, sponsored by Alltech Life Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01731093: Completed Phase 1 study of Oxidative Stress, sponsored by Alltech Life Sciences.
NCT01731093 is a Phase 1 study of Oxidative Stress that has completed, run by Alltech Life Sciences. The registered enrollment target is 24 participants, below the 85-participant average among 36 other Oxidative Stress trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01731093, a Phase 1 study of Oxidative Stress, has completed, sponsored by Alltech Life Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine the safety, bioavailability, and effectiveness of an organic yeast-selenium compound in reducing brain oxidative stress. Oxidative stress in the brain has been linked to a variety oif disorders including Alzheimer's disease. Selenium is a very powerful antioxidant that could prove useful in reducing the harmful effects of oxidative stress in the brain and may help prevent diseases such as Alzheimer's. Our recent work has demonstrated that the specific type of selenium compound greatly influences it's ability to enhance brain health and prevent Alzheimer changes in mouse models of this disease. This study will enroll 24 participants and will allow us to test the hypotheses that yeast-selenium supplementation is safe in the elderly, and that our specific formulation reduces brain oxidative stress.
Primary Outcome
Safety and tolerability will be assessed by analysis of adverse events, including symptoms and abnormal findings on physical examinations and standard laboratory tests (serum chemistry, hematology, and urinalysis).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AT-001
Study Locations (1)
Kentucky
- University of Kentucky Alzheimer's Disease Research Center - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
What the finished NCT01731093 record still lists
NCT01731093 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 85-participant average among 36 other Oxidative Stress trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Oxidative Stress appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01731093 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT01731093 about?
NCT01731093 is a clinical study titled "Safety and Tolerability of Antioxidant (AT-001)for Reducing Brain Oxidative Stress". The purpose of this study is to determine the safety, bioavailability, and effectiveness of an organic yeast-selenium compound in reducing brain oxidative stress. Oxidative stress in the brain has been linked to a variety oif disorders including Alzheimer's disease. Selenium is a very powerful antio...
What is the current status of trial NCT01731093?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-03. Estimated completion is 2013-12.
What conditions does trial NCT01731093 study?
This clinical trial studies the following conditions: Oxidative Stress.
What interventions are being tested in trial NCT01731093?
The interventions under investigation include: Placebo (DRUG), AT-001 (DRUG).
Who is sponsoring clinical trial NCT01731093?
This trial is sponsored by Alltech Life Sciences, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01731093 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01731093's enrollment target sits among peer trials
24 28th of 36 higher than 8 of 36 other Oxidative Stress trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oxidative Stress trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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