Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-01-03 @ 3:57 AM
Study NCT ID:
NCT01731093
Status:
COMPLETED
Last Update Posted:
2014-01-23
First Post:
2012-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of Antioxidant (AT-001)for Reducing Brain Oxidative Stress
Sponsor:
Alltech Life Sciences Inc.
Organization:
Study Overview
Official Title:
Multiple-ascending Dose Clinical Trial of the Safety and Tolerability of Antioxidant (AT-001) Treatment for Reducing Brain Oxidative Stress
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
Placebo-controlled, single-center, multiple ascending dose study. Approximately 8 healthy volunteers will be enrolled into 3 sequential cohorts, for a total of 24 enrolled subjects.
All subjects will be treated with study drug or placebo for 12 weeks. Subjects will be seen in the clinic for the following visits: Screening, Baseline (Day 1), Day 2, Day 4, Day 7 (Week 1), Week 2, Week 4, Week 6, Week 8,and Week 12 while on study drug. An additional safety visit at Week 14 (two weeks after study drug discontinuation) will be required of study participants.
Subjects will undergo blood draws, urine collection, assessment of vital signs, and review of Serious Adverse Events (SAEs) and Adverse Events (AEs) as well as changes in concomitant medical conditions and medications at every visit.
Routine medical examinations will be performed at study screening and enrollment, Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Week 14 visits.
MRI will be performed on all subjects at Screening to ensure safety of lumbar puncture. Research procedures will also include lumbar puncture at the Screening and Week 12 visits.
A designated Data Safety Monitoring Board (DSMB) will evaluate safety in the subjects who have been enrolled and completed a cohort before escalating to the next cohort. The DSMB will review safety data (i.e. any AE or SAE) through Week 14. The committee may also request to review additional data.
The DSMB will also be convened in the event of a dose limiting toxicity (DLT) to determine whether stopping rules for accrual have been met.
All subjects will be treated with study drug or placebo for 12 weeks. Subjects will be seen in the clinic for the following visits: Screening, Baseline (Day 1), Day 2, Day 4, Day 7 (Week 1), Week 2, Week 4, Week 6, Week 8,and Week 12 while on study drug. An additional safety visit at Week 14 (two weeks after study drug discontinuation) will be required of study participants.
Subjects will undergo blood draws, urine collection, assessment of vital signs, and review of Serious Adverse Events (SAEs) and Adverse Events (AEs) as well as changes in concomitant medical conditions and medications at every visit.
Routine medical examinations will be performed at study screening and enrollment, Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Week 14 visits.
MRI will be performed on all subjects at Screening to ensure safety of lumbar puncture. Research procedures will also include lumbar puncture at the Screening and Week 12 visits.
A designated Data Safety Monitoring Board (DSMB) will evaluate safety in the subjects who have been enrolled and completed a cohort before escalating to the next cohort. The DSMB will review safety data (i.e. any AE or SAE) through Week 14. The committee may also request to review additional data.
The DSMB will also be convened in the event of a dose limiting toxicity (DLT) to determine whether stopping rules for accrual have been met.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: