The POLARIS-AD clinical trial is a Phase III clinical trial using AR-1001, also known as mirodenafil, for early stage Alzheimer’s disease. So people with mild cognitive impairment and mild dementia related to Alzheimer’s disease. Mirodenafil is a phosphodiesterase 5 inhibitor often used for erectile dysfunction or pulmonary hypertension. It’s an oral therapy and we completed enrollment at the end of last year and fully enrolled 1,535 participants...
The POLARIS-AD clinical trial is a Phase III clinical trial using AR-1001, also known as mirodenafil, for early stage Alzheimer’s disease. So people with mild cognitive impairment and mild dementia related to Alzheimer’s disease. Mirodenafil is a phosphodiesterase 5 inhibitor often used for erectile dysfunction or pulmonary hypertension. It’s an oral therapy and we completed enrollment at the end of last year and fully enrolled 1,535 participants. We’re very excited. Top line results with this trial will be out later this year. If this clinical trial is positive, meaning we see a signal that’s a difference between the placebo treatment group and the mirodenafil-treated group, we will be very excited. Essentially, the primary endpoint is to look for a change in the CDR sum of boxes. That’s the clinical dementia rating scale. And if we see that difference, this will really change our landscape for Alzheimer’s disease. Not only do we have two disease-modifying therapies thus far, they have limitations. There are certain patients who can’t get these therapies, and the side effects may be limiting. This is an oral therapy thus far in the baseline demographics. It’s very on par with other large-scale clinical trials. And to date, we haven’t had any major safety concerns. So it’s tolerated well, people can take a pill, and we have more options for patients with Alzheimer’s disease. We’re very excited. We also want to thank the patients and caregivers and all of the site investigators for all of the support that we’ve had so far in fully enrolling this clinical trial.
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