Nearly 7 million people in the U.S. are living with Alzheimer’s disease. Researchers continue to study, develop, and bring new treatments to patients who need them most—treatments that can help you stay active, be independent, and improve your quality of life. One such treatment that has shown early promise is AR1001, an investigational oral medication for people diagnosed with early- Alzheimer’s disease and mild cognitive impairment.

Working with AriBio, Charter Research is actively recruiting participants for the Polaris-AD study, a Phase 3 clinical trial designed to demonstrate the treatment’s efficacy in preventing, delaying, or slowing early symptoms of Alzheimer’s disease.

“This new study is a tremendous opportunity for those with early Alzheimer’s to advance—and receive—a potentially effective new treatment,” according to Edgardo Rivera, MD, FACEP, Medical Director, Charter Research and Principal Investigator for the study in Orlando.

What is the Polaris-AD study for early Alzheimer’s Disease?

Originally developed in South Korea for the treatment of erectile dysfunction (ED), AR1001, known as a PDE5 inhibitor, is marketed there as the drug Mirodenafil. How did an ED drug become a candidate for the treatment of Alzheimer’s? Men taking the drug during earlier clinical trials for ED were shown to have better cognitive results after eight weeks of daily usage.  

In pre-clinical and Phase 1 and 2 Alzheimer’s studies, AR1001 was found to improve cognition and mood in some patients, potentially improve blood supply to the brain, and was well tolerated.

In this Phase 3 study, researchers will seek to understand if the drug will improve cognitive function. The study will also measure biomarkers—an objective measure of what’s happening in cells—in blood as well as in cerebrospinal fluid (which surrounds the brain and spinal cord). The fluid will be collected by a lumbar puncture procedure before and after the study, and the results will be compared.

“Looking at biomarkers will help us determine if the disease is there, active, and whether or not it’s improving,” Rivera explains. “Each biomarker will tell us something different and there are also biomarkers which will be more comprehensive and give us an entire picture of what is happening.”

As a double-blinded, randomized, placebo-controlled study, participants will either receive the medication or a placebo. “Neither the participants nor the researchers will know which treatment they’re receiving, which removes any possible bias on either side,” Rivera said. The study will run in two stages, each for 52 weeks. The first stage is randomized, with participants receiving either the study drug or placebo. During the second stage, every participant will receive the study drug (no placebos). This second stage is what’s known as an “open label” study.

What are the potential benefits of the new drug?

Unlike the recently FDA-approved Kisunla and other infusion therapies for Alzheimer’s, AR1001 is an oral medication that’s taken once a day, which makes it an easier and more convenient option.

AriBio Co. also claims that the drug is 10 times more potent and better at entering the brain than similar medications. “While potency doesn’t mean the drug is better, the amount of drug that is required to achieve the same effect is lower, potentially reducing the risk of side effects,” Rivera said.

Since the drug also works in a different way and targets a different pathway in the body than other approved Alzheimer’s drugs, it has the potential to be a combination therapy. “If approved, patients will potentially be able to take it with another Alzheimer’s drug which will further enhance their treatment,” Rivera said.

If AR1001 passes Phase 3 clinical trials, patients could expect to see the drug come to market within the next 3 to 5 years.

Who is eligible for the early-Alzheimer’s Disease study?

If you’re between the ages of 55 and 90-years-old and have signs and symptoms associated with mild-stage Alzheimer’s disease such as memory, planning, and organizational issues, but you can complete most daily tasks on your own, you may be eligible for the clinical trial.

After the prescreen assessment, you will undergo an initial lumbar puncture to confirm a positive biomarker for the disease. The trial runs for at least one year, with the option to continue for another year with the extension phase.

To learn more about the clinical trial call Charter Research at 407-337-3000 (Orlando) or 352-441-2000 (The Villages). You can also fill out the form on the Early Alzheimer’s Study page, and one of our representatives will call you within 24 hours (excluding weekends).