NCT03062384

AT-001 for Long-term Preservation of Brain Health in Aging

AT-001 for Long-term Preservation of Brain Health in Aging: The ALPHA Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: University of Kentucky · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Oxidative Stress

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	AT-001
DIETARY_SUPPLEMENT	Placebo

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2017-02-23
• Last updated: 2019-08-20

Locations

1 site across 1 country: United States