They have Alzheimer’s disease and this clinical trial could be their last hope

Despite the urgent need for treatments to slow or stop Alzheimer’s disease, finding patients for clinical trials has been difficult and frustrating. The patients are generally older. Your doctors may not be part of a research network. And many dementia patients never get a diagnosis, either because their doctors don’t tell them what’s wrong or because they avoid finding out they have the dreaded disease.

“How do you recruit when patients don’t realize they’re candidates?” Asked Michelle Papka, director of the Cognitive and Research Center, a clinical trials center in Springfield, NJ.

Its center is one of 290 participants in a new study from drugmaker Eli Lilly and Co. that plans to enroll 1,500 patients. The company hopes to confirm the results of its smaller study, lasting 76 weeks, in 257 patients. It was discovered that the investigational drug donanemab significantly slowed the progression of Alzheimer’s disease, the first time that a study of a disease-modifying drug had achieved its main goals.

“I’d be surprised if this wasn’t a popular study,” said John Dwyer, president of the Global Alzheimer’s Disease Platform Foundation, a network of clinical trial centers contracted with Lilly to help speed patient recruitment.

But where will the patients come from?

They must have the right degree of brain damage; if it’s too much, it’s probably too late. If it is too little, it may take a long time to see the effect of the drug, if any. They often have to experience the study on their own. They must agree to receive regular infusions of what could be a placebo for more than a year.

Plus, if they or their family members have paid attention to the state of Alzheimer’s drug research, they will know that study after study of what appeared to be a promising treatment for the disease. Alzheimer’s failed, to the point that some companies, after spending billions on futile attempts, decided to quit the Alzheimer’s drug development business.

Three people who arrived at a New Jersey clinical trials center on March 26, a foggy Friday morning, offer answers about who might enroll and why.

I said, “ No way, I don’t ”

A few years ago, Michael Gross, 73, of Mahwah, NJ, began to realize that something was wrong. “I didn’t know what words to use, and it just got worse,” he said.

However, Gross, a retired director of an advertising agency, was surprised when a doctor suggested he have a lumbar puncture to look for proteins that are a sign of Alzheimer’s. He couldn’t have this disease, Gross thought.

“I said, ‘No way, not me,'” he said.

Nonetheless, he did.

He was crying, he was in despair.

Then he wondered what he could do about it.

He opted for the Mediterranean diet. He started to exercise. He started doing crossword puzzles and signed up for a brain training program. He found a study in mice that claimed bright light directed at their heads helped fight Alzheimer’s disease. He bought the light.

The disease continued to progress. You can no longer remember the details of a story while reading it.

Gross, a longtime Yankees fan, was baffled the day he forgot the name of former team coach Casey Stengel and insisted on keeping it in his memory.

“Every day I wake up and I’m like, ‘Casey Stengel, Casey Stengel’,” he adds.

Gross saw an ad on Facebook about Lilly’s clinical trial. This Friday morning, he took a test to see if he was in good shape. It was a brain scan to detect a protein, tau, which is found in dead and dying brain neurons. If it had too little tau it wouldn’t fit.

He underwent another test, an MRI of the brain, and found that he had been accepted for the test.

What if you don’t get the medicine? Or if the drug fails?

Then he will look for other trials, Gross said. You’ll even consider a treatment you’ve recently heard of. “They inject something into your nostril, and it supposedly heals you,” he says.

His wife, Peggy, joined the conversation.

“We haven’t reached a point where we admit there is no help for him,” he said.

“ It got to a point where it was very real ”

The next patient to arrive was a 63-year-old woman who is enrolled in the trial and who has already received two infusions of the drug or placebo. She and her husband have requested that their names not be used as they have yet to disclose their diagnosis to friends and family.

She is a happy optimist but, due to her illness, she lets her husband talk the most. When her memory began to falter a few years ago, she and her husband attributed it to the stress of working as an occupational therapist.

“I don’t think we were thinking about Alzheimer’s disease,” her husband says.

However, her memory problems continued even after she quit her job. He would go shopping, with a list, and he would forget the things on the list. He forgot the appointments.

“It got to a point where it was very real,” her husband said.

He took his wife to a neurologist who did a series of tests. The results were not good.

“For the first time, he went from a memory problem to something alarming,” the husband said. On March 6, a lumbar puncture confirmed the probable diagnosis: Alzheimer’s disease.

The man and his wife were distraught. No medication, no change in lifestyle changes the course of the disease. Their doctor didn’t refer them for a clinical trial, but their oldest son, a sophomore medical student, found Lilly’s trial for them.

The woman doesn’t expect a cure, but said, “I hope I don’t get worse. I don’t want to be a talkative idiot. If I can continue like this, I will be happy. I crochet, I color and I walk the dog ”.

“ There wouldn’t be a COVID vaccine if people hadn’t volunteered ”

Bob Lippman, 78, of Summit, NJ, was diagnosed with Alzheimer’s disease in November 2017, after a year and a half of increasing symptoms. He found out about Lilly de Papka’s trial and was accepted. She received her second infusion in central New Jersey this Friday morning.

Lippman now has difficulty speaking, so his wife, Marlene, shared his story.

“I have said it a lot and asked myself the same thing over and over again,” he said. “He forgot entire conversations. At first, I thought it was normal aging ”. However, after listening to a speaker from the Alzheimer’s Association at Sage Eldercare, a nonprofit near her home in Summit, New Jersey, she realized that what her husband was going through was not normal.

Memory tests confirmed these fears and a brain scan that detected amyloid, the stiff balls of plaque that characterize Alzheimer’s disease, made the diagnosis.

He started making plans: remaking wills and powers of attorney. She found a support group for caregivers at Sage, as well as Lilly’s trial.

You know what to expect. If her husband is given the drug and not the placebo, and if the drug is as effective as it was in the initial small study, “at best it could delay the course of her deterioration,” she said. . “It sure won’t cure him.”

“Our main motivation is to help other people and to move the investigation forward,” he added. “There wouldn’t be a COVID vaccine if people hadn’t volunteered.”

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