If you know anyone who has struggled with Alzheimer’s and the people who love them, you know what a cruel disease this is and how desperate they are for a cure. Well, Eli Lilly may be one step closer to finding them help as researchers there advance their research and treatment with a drug called donanemab. A clinical trial of the experimental drug found it slowed the worsening of memory and thinking. In the trial published, it made it clear it only worked modestly, but it’s progress.
So what is this drug, and how soon could it be available?
Breaking It Down
First, let’s break down how you even say the word. Dononamab is pronounced as dough-NO-nuh-mab. It’s made by Eli Lilly, and the company is hoping to get FDA approval for it by the end of the year. In mid-July, Eli Lilly presented the final results from an 18-month phase three trial on a monthly antibody infusion of the drug, which showed it significantly slowed disease progression.
Like most diseases, it’s essential to treat Alzheimer’s patients as early as possible when symptoms are mildest and the chances of slowing cognitive decline are highest. The drug trial, which involved 1700+ patients, showed it’s most effective at slowing memory loss and cognitive function if it’s taken in the early stages when there’s less of a protein that creates crisscross in the brain. They found it worked better in patients at earlier stages and in those under 75 years old.
How Does it Work?
The drug was given in an IV, in monthly infusions, to attack amyloids. In the study published in the journal JAMA, people in earlier stages taking donanemab saw a slow decline in memory and thinking by about four and a half to seven and a half months over an 18-month period, compared with those taking a placebo. Those with less of the damaging protein (referred to as tau) saw the most pronounced slowing of decline if they were younger than 75, along with those with mild cognitive impairment, a pre-Alzheimer’s condition. They documented that the sooner you could get treatment, the more impact you could expect.
What You Need to Know
That said, it’s important to know the drug did pose significant safety risks, including death in serious cases or swelling and bleeding in the brain, which could be serious. It also doesn’t reverse brain damage already caused by the disease.
Another key point to get across is that the slowing was so modest that patients and their families may be unable to notice the difference after taking the drug. The findings showed those taking the drug saw a decline that was 29 percent slower than the placebo group, which is a difference of seven-tenths of a point. But many Alzheimer’s experts say for the slowing of decline to be clinically meaningful or noticeable, the difference must be at least one point. So again, it’s slow progress so far, but it is in the right direction.
And there’s more good news. In the trial, patients were no longer given donanemab once their amyloid was cleared below a certain threshold. They were then given a placebo. About half of the patients hit that threshold within a year, and their decline continued to slow even on the placebo.
The trial found that the intermediate group (which was larger) experienced a 36 percent slowing of decline, compared with 29 percent for the combined intermediate and high tau groups and 21 percent in the high tau group alone. Another scale, which was the trial’s primary measurement tool, showed the same pattern. Lilly calculated that the decline for patients in the intermediate group would be slowed by 4.4 to 7.5 months over 18 months compared to people on placebo, while the combined population would see a slowing of 2.5 to 5.4 months.
More people with intermediate tau (the protein) remained at the same cognitive level in their first year of the trial. The study estimated that was 47 percent, compared with 29 percent of people in the placebo group. In the combined tau groups, 36 percent of people on donanemab remained at the same level compared with 23 percent of people on placebo.
The company also reported that donanemab patients with mild cognitive impairment in the intermediate tau group slowed by 46 percent, while those who had already progressed to early Alzheimer’s slowed by 38 percent. Intermediate tau patients who were younger than 75 slowed by 45 percent, while older patients slowed by only 29 percent.
Continuing Studies
There is criticism that the majority of the study’s patients were white. However, Black, Hispanic, and other historically marginalized communities have a higher risk of Alzheimer’s, so more studies should include more patients from these groups.
All that said, this study did show that donanemab could be a significant advancement in early symptomatic Alzheimer’s disease research and treatment. Knowing that clearing the amyloids from the brain will slow the disease progression is helpful. Also, knowing that getting treatment as early as possible will lead to a bigger benefit, along with the potential of slowing disease progression even if treatment comes later, is helpful as those suffering from this cruel disease grapple with what to do next.
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