CLEVELAND — John Domeck has a knack for puzzles. Word games and reading have always been enjoyable pastimes for the now retired attorney.

What You Need To Know

  • The FDA granted accelerated approval for a new Alzheimer’s disease drug called lecanemab.

  • It’s a big step. Currently, there’s only one other FDA approved treatment for the degenerative and fatal brain disease often associated with memory loss.

  • The medication is only for a small group of patients and comes with concerns about side effects and cost.

“I still read 800 page history books," he said.

But for the last few years, these activities are to help him keep his cognitive abilities intact.

His wife, Ann, remembers feeling shocked when he was diagnosed with early-onset Alzheimer’s disease in 2019 at age 57.

“Absolutely astounded us," Ann Domeck said. "Threw us back."

Every other week, the couple comes to the Cleveland Clinic for infusions of lecanemab.

John joined a clinical trial in 2020, and the drug was recently approved by the FDA through an accelerated process.

“It really is a big deal because any hope in a hopeless situation is amazing," Ann Domeck said.

Lecanemab is an antibody made in a lab that targets the amyloid beta protein in the brain of Alzheimer’s patients.

It slows down the progression of the disease, but is not a cure.

Dr. Babak Tousi is leading the clinical trial at the Cleveland Clinic Lou Ruvo Center for Brain Health.

“The point is within the 18-month period of the trial we see the group who received medication compared to the group who received placebo. The rate of decline was 27% less," Tousi said. "It is small, but still promising when we don’t have any other treatments available."

But it’s not for everyone. The therapy is for patients with mild cognitive impairment (MCI) that are in the early stages of Alzheimer’s and have a buildup of amyloid plaques in the brain.

“I know there aren’t a lot of people that it’s helping, but for those of us that it’s helping, it means the world," Ann Domeck said.

There are some risks. The treatment has been linked to brain swelling and brain bleeding and may not be suitable for those taking blood thinners.

“Ask anybody who has a disease eating away at your brain and there’s nothing to do for it, would you rather just sit there and deteriorate or would you try to fight a little even though this, this, this could happen," Ann Domeck said.

John has had no side effects since taking the drug, and his cognitive tests have been stable for two years now. 

But his short-term memory isn’t what it used to be.

John first started showing signs that something was wrong at work about a year before he was diagnosed. He noticed needing to take more notes to keep things straight and later Ann picked up on other changes at home.

“Little bit of a personality change and a vagueness that wasn’t there before and he didn’t remember things we talked about a day before, things we talked about an hour before," she said.

John and Ann have been married 37 years and traveling together has always been one of their favorite things to do. Since the diagnosis, they’ve had many great trips around the world.

“I wasn’t born with a sense of direction and John’s isn’t great anymore when he’s in a new place," Ann Domeck said, laughing. "So, we get lost sometimes."

Humor helps. John still drives and plays golf, even if he doesn’t always keep track of each swing.

“I’ve improved my score greatly," John Domeck said. "Amazingly, without getting better."

Leaning on their faith and each other has made a big difference.

Life’s focus now is making every moment count.

“It's not a hardship, just something to live with and accept," John Domeck said.

Right now, the Centers for Medicare & Medicaid Services (CMS) is not offering insurance coverage for lecanemab outside of those part of clinical trials. That decision came out before the FDA's accelerated approval.

The Alzheimer’s Association overall is thrilled to have this second treatment approved by the FDA, but the focus now is making it available to patients who are not in a clinical trial. It’s estimated to cost about $26,000 a year out-of- pocket.

“Usually when things are approved by the FDA, the Centers for Medicare & Medicaid Services do go along and approve them and the fact that they have eliminated an entire class of drugs is very unusual as well," said Jennifer Lepard, region lead for Ohio, Michigan and West Virginia at the Alzheimer’s Association. "So, that’s why we are continuing our conversations and certainly letting them know where we stand and really thinking that this is a mistake to not have this drug therapy be available."

The Alzheimer’s Association has submitted a formal letter of reconsideration to CMS and hopes they will take another look in order to increase patient access to the new medication.