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 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Multiple-ascending Dose Clinical Trial of the Safety and Tolerability of Antioxidant (AT-001) Treatment for Reducing Brain Oxidative Stress|
- Frequency of adverse events [ Time Frame: Baseline to week 14 ] [ Designated as safety issue: Yes ]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).
- Change in serum selenium levels [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
- Change in cerebrospinal fluid selenium levels [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
- Change in serum, urine, and cerebrospinal fluid isoprostanes [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Study Completion Date:||December 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731093
|United States, Kentucky|
|University of Kentucky Alzheimer's Disease Research Center|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Gregory A Jicha, MD, PhD||University of Kentucky|
|Study Director:||Ronan Power, PhD||Alltech Inc.|