So a high-level overview of this is that this is really designed as a gold standard Alzheimer’s disease modifying trial, meaning you have to treat for about a year or more. And we’re looking at patients with mild to moderate Alzheimer’s in the 12 to 24 range on that scale I referred to as the Mini Mental State Exam, MMSE. So it’s mild to moderate Alzheimer’s. We’re testing two different doses of atuzaginstat, well separated to increase our chance of seeing efficacy and seeing a dose response curve...
So a high-level overview of this is that this is really designed as a gold standard Alzheimer’s disease modifying trial, meaning you have to treat for about a year or more. And we’re looking at patients with mild to moderate Alzheimer’s in the 12 to 24 range on that scale I referred to as the Mini Mental State Exam, MMSE. So it’s mild to moderate Alzheimer’s. We’re testing two different doses of atuzaginstat, well separated to increase our chance of seeing efficacy and seeing a dose response curve. And as I said, it’s pretty gold standard design with two exceptions that I’ll show you in a sec.
So the co-primaries are widely accepted by regulatory authorities in the U.S. and around the world, a cognition scale and a functional scale of activities of daily living. And standard secondary outcomes, we will look at Winterlight again. And the standard accepted biomarkers for Alzheimer’s: amyloid beta, tau, and phospho-tau in the cerebrospinal fluid.
But one of the interesting things that’s different about this study is we’re also looking at biomarkers of P. Gingivalis infection and other signs of inflammation and neuroinflammation in blood, saliva, and other areas. The other way in which this is a particularly unique Alzheimer’s trial is this periodontal sub-study. So at about a third of our clinical trial sites, they had an affiliated dental site nearby where the patient could go and get dental exams, because we know that this bacterium is critical for causing periodontal disease and our drug is designed to stop it. So we’re hoping to see an improvement on periodontal.
And as you can see on the lower left, the study was started in early 2019. We completed all enrollment in September of 2020. And we are expecting top-line data in this next quarter. We have statistically powered the GAIN trial to have a 90% chance to see a 50% reduction in the decline that inevitably accompanies Alzheimer’s disease. And in the mild-moderate range, this would be a very significant improvement for people with Alzheimer’s and obviously family members and all the many others who are impacted so significantly by Alzheimer’s.
