As you may know, an indicator of Alzheimer’s in brain cells is the buildup of two types of proteins. Amyloid proteins clump together in sticky plaques outside of brain cells, while tau proteins get tangled up inside the cells.

In 2023, the FDA approved an Alzheimer’s drug called lecanemab (brand name Leqembi) that targets amyloid plaques. Now, the maker of lecanemab, pharmaceutical company Eisai, has created a new investigational medicine that tackles tau tangles. This new investigational drug is a special type of antibody that is designed to recognize a specific part of the tau protein, bind to it, and neutralize it before the tangles spread to other brain cells.

Exploring the effects of coupling a new delivery method for lecanemab (intra-muscular auto-injection) with a new investigational anti-tau drug, researchers think using these drugs in combination could possibly deliver a one-two punch to slow the progression of Alzheimer’s.

Because the combination of the two medicines targets both amyloid plaques and tau tangles, scientists want to know if giving both treatments to patients may possibly be more effective than using lecanemab alone. This clinical trial will evaluate the effect of four different dosing levels of the anti-tau drug given with lecanemab, as well as just lecanemab alone, without the anti-tau investigational drug.

A number of research centers around the world, including Charter Research in The Villages, are recruiting people between the ages of 50 and 80 with a diagnosis of mild Alzheimer’s disease to participate in the study. Study participants need a study partner—typically a spouse, other family member, or close friend—who can support them during the trial.

Those who join this clinical trial will receive personalized care and health information, including comprehensive tests that are difficult to obtain outside of research—all at no charge. In addition, all study participants will receive lecanemab and may also possibly receive the investigational anti-tau drug, code named E2814.

The Study Screening Process

To determine their eligibility for the study, participants will take part in a screening process that includes a cognitive test, blood tests, a heart check (ECG), and a brain scan (MRI). According to Dr. Jeffrey Norton, the lead investigator on this trial, the screening tests alone are well worth participants’ time, even if they ultimately learn they’re ineligible for the trial.

“The screening provides information you can’t easily get from your regular doctor. It’s worth the time investment, especially if you have symptoms or a strong family history of Alzheimer’s,” Dr. Norton said. “You’re essentially getting a free medical evaluation. If you pass the cognitive and other tests, getting a PET scan—which is nearly impossible to access right now whether you’re a Medicare patient or not—is a significant benefit.”

The Positron Emission Tomography (PET) scan gives doctors important information about molecules in your brain that can indicate Alzheimer’s disease.

The Study Structure

The clinical trial lasts about 2 years, including a treatment period of 79 weeks and a 12-week follow-up period. During the study, patients visit Charter Research in The Villages, receiving study medication and participating in clinical assessments. Dr. Norton says that patients will need to visit the clinic once a week for the first eight weeks to receive lecanemab, and then once a month thereafter.

Patients in the trial will be randomly assigned among five different groups. One group of participants will receive lecanemab and a placebo. The remaining participants will be divided equally and randomly among the four other groups, each receiving lecanemab and a different dosage of the investigational anti-tau medication.

The trial is “double blind,” meaning that neither study participants nor the medical staff know who is receiving the investigational drug until after the trial is complete.

Dr. Norton commented, “By joining the clinical trial, you’ll help advance research, contribute knowledge toward slowing Alzheimer’s disease, and potentially see an extended quality of life for yourself.”

Ready to get started?

If you’re interested in discussing participation in this clinical trial, simply click this link, fill out the short form on the page (“Sign Up”), and we’ll follow up with you about your eligibility.

You can also call us at:

The Villages, 352-775-1000