If you or a loved one has mild to moderate Alzheimer’s disease, you know that forgetting words, losing or misplacing items, and feeling moody can affect your everyday life and the activities you once enjoyed.

While several new Alzheimer’s drugs such as donanemab (Kisunla) and lecanemab (Leqembi) have become available over the last few years. These are intravenous (IV) infusion therapies aimed at removing amyloid plaques from the brain, requiring a trip to the infusion center every month—or more frequently—and are time-consuming to administer.

Working with Lilly, Charter Research is actively recruiting participants for a Phase II clinical trial of the oral medication mevidalen. “If approved, mevidalen could be a game changer and provide a safe, effective, and more convenient treatment option than infusion therapies, as well as much-needed hope for patients and their caregivers,” says Diana Balsalobre, MD, a neurologist and Principal Investigator for this study at our Orlando location. This study is also open for enrollment at our location in The Villages.

What is this study about?

Patients with mild to moderate Alzheimer’s disease often have negative changes in how efficiently their bodies process dopamine, which can lead to problems with personality, mood, and behavior. “Since mevidalen is what’s known as a dopamine D1 receptor positive allosteric modulator (DETQ), researchers think this investigational drug may also have positive effects on irritability, anxiety, apathy, physical activity, sleep, and wakefulness,” Balsalobre said. This type of DETQ enhances the body’s ability to utilize dopamine. In theory, this may boost dopamine’s effectiveness in someone with Alzheimer’s.

The mevidalen study will look at whether the drug is a safe and effective treatment to improve thinking (cognition), memory, and executive function in patients with mild to moderate Alzheimer’s disease.

This Phase II clinical trial will be the first time researchers will test the drug for those with Alzheimer’s disease. Previous clinical trials looked at the drug in those with Parkinson’s disease and Lewy body dementia (LBD). As a randomized double-blind placebo controlled study, you will receive either a low or high dose of the drug, or a placebo.

An alternative

Another advantage is that unlike the anti-amyloid treatments which require patients to sit for an intravenous (IV) infusion, mevidalen— as an oral medication—would be more a convenient option. “Taking a pill at home is a lot easier than coming to an infusion center every month or every 2 weeks for years,” Balsalobre said.

A majority of research and drug development for Alzheimer’s disease has thus far been focused on anti-amyloid monoclonal antibodies, but if mevidalen is approved, it could provide yet another option for patients. “At the end of the day, we’re going to have to look at inflammation and other factors [as the cause for Alzheimer’s], and I think patients will use a variety of treatment approaches, which this new drug could offer,” Balsalobre said.

If clinical trials also show that mevidalen is an effective treatment for mood and sleep issues, some patients may be able to reduce the number of medications they’re taking, which would also ease the burden for caregivers who are tasked with managing medications, Balsalobre said.

Who is eligible for the mevidalen study?
If you’re 50–80 years old, have signs of mild to moderate Alzheimer’s Disease, and gradual and progressive decline in memory function for 6 months or more, you may be eligible for the study. You will also need a reliable family member or caregiver who can provide support to you throughout the study.  A total of 300 participants worldwide will be enrolled in the study, which will run for 24 weeks, and then patients will follow up for 26 weeks.

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 this page, and one of our representatives will call you within 24 hours (excluding weekends).