Jennifer Loveless said she remembers some things about her and her husband John’s visit to the Cleveland Clinic in January 2017.
Multiple Assessments. Cognitive Testing. Blood Work. A Lumbar Puncture.
The next thing she remembers is hearing the words: Alzheimer’s Disease.
Her husband, John Loveless, was diagnosed with early-stage Alzheimer’s disease. At the same appointment, doctors at the Cleveland Clinic mentioned a clinical trial he could enter for an Alzheimer’s drug being tested.
But that important fact was lost in a fog of devastation. “When you get a heavy diagnosis such as that, it’s almost like you can not even comprehend anything after that. I do recall them mentioning there was a clinical trial available that John could be getting into in the third phase,” Mrs. Loveless said.
That clinical trial was to test aducanumab. On Oct. 22, Biogen, a global biotechnology company based in Cambridge, MA, announced plans to pursue regulatory approval from the U.S. Food and Drug Administration (FDA) for the investigational drug. If approved, aducanumab would become the first treatment ever that reduces the clinical decline of Alzheimer’s disease.
Eric VanVlymen, Executive Director of the Alzheimer’s Association Miami Valley Chapter, said, “We are encouraged by the news and the opportunity for a disease-modifying drug. This would be the first treatment to actually address the disease not symptoms.” He added, “But while our mission is focused on providing care and support for all impacted by the disease, at the same time we believe in and are driven by scientific evidence. Because of that, we look forward to the analysis of data.”
The last Alzheimer’s drug approved by the FDA was Namenda, around 15 years ago, said Dr. Kenneth Pugar, President and Founder of the Dayton Center for Neurological Disorders. The petition to the FDA for aducanumab is based on newly-reported Phase 3 clinical trial results in which the company found a significant reduction of cognitive and functional decline in patients with mild dementia or mild cognitive impairment (MCI) due to Alzheimer’s disease.
“It did not cure the disease, but it slowed down the progression in patients with early Alzheimer’s disease or mild cognitive impairment,” Dr. Pugar said. “So, this is exciting if we have anything that slows down the disease.”
“While I have some skepticism, I also have some optimism,” Dr. Pugar said. “Maybe we finally got a little chink in the armor of this disease.”
John Loveless said, “the news is actually surprising to me because in my mind, there were some doubts. They stopped the trial, so I thought that meant the drug was not working. Now that they are bringing it back, it must mean they have some notice that it is working.”
In fact, in March 2019, Biogen announced it would discontinue its Phase 3 trials for aducanumab after an interim analysis showed the drug was not likely to produce a meaningful benefit. However, after adding three more months of data, they found that participants, who had been given a higher dose of the drug for longer periods of time, experienced significant reduction in clinical decline.
It took about six months for John Loveless to qualify for the clinical trial. “They were pretty selective of who could enter the trial,” Mrs. Loveless said. “You had to be in reasonably good health and be in the early stage of Alzheimer’s disease. John just happened to fit that mold,” Mrs. Loveless said.
John Loveless was in the trial for 20 months. He said in the beginning, “I didn’t really understand what a drug trial meant.” Once a month, he would go to The Ohio State University Wexner Medical Center for an infusion of the drug. Every few months, he would get an MRI and other cognitive testing to measure the results.
“Being in a trial you don’t know what the outcomes are going to be, but even if the trial failed, they would have learned something, so it is certainly a benefit as well,” he said.
Jennifer Loveless said she saw some positive impacts- more clarity, sharpness and energy. After getting over the grief felt around the diagnosis, she said they decided to pair his participation in the trial with an effort to do everything they could to adopt a healthier lifestyle.
“Positive outlook makes a difference on anybody’s well-being or health,” she said. “We know that pushing ourselves every day, finding new joy in each new adventure, we felt like it was a culmination. It was allowing him to free up some brain space. I would say during that time, I saw an improvement in my husband. Was it the drug? Was it our attitude? Was it our push to be healthy? We just don’t know.”
Biogen has announced that while it seeks FDA approval, it will provide the drug to Phase 3 participants. Because of that, John Loveless said he feels, “very fortunate” to be able to take the drug again.
“For it to have been abruptly halted that was devastating to the both of us,” Mrs. Loveless said. “John felt like he was playing his role in the movement to find a cure… So, to get this news that John would actually be eligible to receive the medication again, not only are we astonished but it just restores hope for us. Like the doctors, we don’t want to hang all of our hope on that, but it is something to be celebrated.”