In the last few years, there have been significant advancements in the treatment of Alzheimer’s disease. With the FDA approval of Leqembi and Kisunla, two anti-amyloid drugs, research and drug development show no signs of slowing down. While all of the drugs on the market are used for people who have Alzheimer’s disease (AD) or dementia—either to treat symptoms or slow disease progression—there aren’t any that have been shown to prevent the disease from ever emerging. Yet a promising new drug known as remternetug may change that, providing hope to millions of people worldwide.

Working with Lilly, Charter Research is actively recruiting participants for a new Phase III clinical trial. In previous clinical trials, remternetug—the investigational drug—has been shown to have a “rapid and robust” reduction of amyloid plaque in the brain, the hallmark sign of Alzheimer’s disease.

“To give someone a medication that could potentially prevent the development of their disease, or at least delay it so it doesn’t become the burden that we all know Alzheimer’s disease to be, is groundbreaking,” according to Stephen Miller, MD, Principal Investigator at Charter Research.

A promising new drug for early Alzheimer’s disease?

The clinical trial for remternetug, known as the LAKI study, is a randomized, parallel-group, double-blind, placebo-controlled Phase III clinical trial. The goal of the study is to determine whether or not the drug is effective in playing a role in delaying the onset of—or preventing—Alzheimer’s disease.

What makes this study unique is that researchers are only including healthy people who do not have an Alzheimer’s diagnosis, but may have early signs of AD. They may have changes in their brain or have very mild symptoms or mild cognitive impairment, including forgetfulness and difficulties with memory. 

Remternetug is similar to donanemab and lecanemab, two monoclonal antibody treatments that are currently on the market and work to remove toxic amyloid plaques in the brain. Amyloid plaques are one of the first signs of the disease, but clearing them early in the disease progression can help prevent cognitive decline or progression of the disease.

“The study will determine if the drug reduces amyloid plaque in the brain, lead to a meaningful slowing of cognitive decline, and if it’s safe and tolerated,” Miller said. “After the trial, we may also find that it’s safer and more tolerable than donanemab and lecanemab, but with the same efficacy.”

If remternetug passes clinical trials, it can also provide an easier, more convenient option for patients. Other monoclonal antibody drugs for Alzheimer’s are administered by IV infusion, but remternetug can be given as a subcutaneous (under the skin) injection using a short needle.

“Receiving a treatment every 8 weeks at home is less time-consuming and more attractive than an IV infusion which patients have to sit for in a clinic for a few hours, every 4 weeks or even more frequently,” Dr. Miller said.

What is the study design?

As a randomized, parallel-group, double-blind, placebo-controlled study, one group will receive the treatment while another will receive a placebo for the duration of the study. Approximately 1,200 people will be enrolled. The study will run for 52 weeks and participants may continue for another 76 weeks in an optional extension period.

After undergoing the initial screening process, participants will receive the treatment every other month. People will initially receive treatments at the research center but can transition to administering the medication at home if they choose. They will also complete cognitive assessments at both the research center and virtually. During the extension period, those who are given the placebo during the initial study timeframe will have an opportunity to receive the investigational treatment.

Like the old adage, an ounce of prevention is worth a pound of cure, remternetug could be the promising new drug that provides hope to millions of people and their families for years to come. “If remternetug is found to be an effective drug that prevents—or significantly delays—the development of dementia as a result of Alzheimer’s disease, it could change how we think about the disease and pave the way for similar treatments.”

What Study Participants Should Expect

From the moment Deltona resident Frances Porter, 77, learned about Charter Research, she says her experience has been nothing but positive. “They contacted me, and I thought, what do I have to lose?” she recalled. “Everyone there was very professional, yet friendly and I didn’t feel threatened in any way from that very first meeting with them.”

For more than two years, Porter has been enrolled in the AHEAD study. AHEAD is similar to the LAKI study in that the treatment is similar (monoclonal antibodies) and the end goals both include preventing Alzheimer’s Disease in healthy, asymptomatic individuals. Participants receive FDA-approved lecanemab via IV infusion every two weeks—and it’s something Porter looks forward to. “I used to tease that this was like a spa day for me,” she explained. “It’s been a wonderful experience, and I can’t believe it’s for research.”

Carol Cruzen, a 73-year-old resident of Orlando, says her experience with Charter Research has also been meaningful and rewarding. After losing her father to Alzheimer’s disease nearly 16 years ago and being told by his doctor there was nothing they could do, Cruzen says she knew if there was ever a research opportunity, she would jump at the chance.

Now enrolled in the same AHEAD study, Cruz says she experienced some apprehension initially, but the staff and a friend she made along the way put her mind at ease. “I see now being in a study is an advantage for me to possibly contribute to the development of a drug that may slow or possibly even stop Alzheimer’s and if it’s something that develops, I will receive the drug,” she said.

Who is eligible for the remternetug study?

If you are between the ages of 55–80, have not been diagnosed with Alzheimer’s but have experienced a gradual and progressive change in memory, cognition, and function for more than 6 months, you may be eligible for the clinical trial. You will also need a reliable study partner, a family member, a friend, or a caregiver who can provide support to you throughout the study.

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