HWN Suggests

New Alzheimer’s drugs don’t deserve the hype – here’s why

Sadly, I don’t think these drugs can make a big difference for people currently, or soon to be, living with Alzheimer’s disease. Also, the shortcomings are so profound, despite decades of expensive trials and patient sacrifice, I think it’s time to take the amyloid blinkers off and prioritise exploring other, neglected, options for treating dementia.

This isn’t the beginning of the end of Alzheimer’s, but perhaps it should be the end of the anti-amyloid drug pathway.

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 FDA approves a second Alzheimer's drug that can modestly slow disease

The FDA approved Kisunla, known chemically as donanemab, based on results from an 18-month study in which patients given getting the treatment declined about 22% more slowly in terms of memory and cognitive ability than those who received a dummy infusion. The main safety issue was brain swelling and bleeding, a problem common to all plaque-targeting drugs.

Articles of Interest

Donanemab: The Breakthrough Drug Ushering a New Era in Alzheimer’s Treatment

Like the two other new Alzheimer’s drugs, donanemab was associated with ARIA, amyloid-related imaging abnormalities that may include brain swelling and microbleeds. Serious ARIA occurred in 3.7% of patients, including three fatalities. Risks were higher among patients with the APOE4 gene, which increases Alzheimer’s risk. For this reason, Rabinovici recommends genetic testing prior to monoclonal antibody treatment.

Alzheimer’s drug donanemab has been hailed as a ‘turning point’ for treatment. But what does it mean for people with the disease?

But as usual, there’s more to the story. The study only included people with early or mild disease, not more advanced symptoms. Donanemab is not a cure for Alzheimer’s. Nor is it 100% safe.

Alzheimer’s Drug Donanemab Helps Most When Taken Early in Disease

An Alzheimer’s drug that attacks the protein amyloid does not work as well in people with more advanced disease.

Alzheimer’s drugs are a ray of hope. They must be accessible to all, not the wealthy few

Developing treatments for Alzheimer’s has been a challenge, with almost 20 years passing with no new drugs. But in the last year, two new ones have emerged: donanemab and lecanemab. Neither are cures or magic bullets for the disease, but they do address key symptoms.

An experimental Alzheimer's drug outperforms one just approved by the FDA

"This is the biggest effect that's ever been seen in an Alzheimer's trial for a disease-modifying drug," says Dr. Daniel Skrovonsky, director of research and development at Eli Lilly, which makes donanemab.

Eli Lilly's Alzheimer's Drug Shows Greatest Benefit Yet

In the Phase 3 study, which included more than 1,000 people with early signs of Alzheimer’s disease, people receiving donanemab experienced 35% slower cognitive decline, as measured on cognitive tests, than people receiving placebo. In addition, those getting the drug showed 40% less decline in the ability to perform daily activities such as driving, managing their finances, and holding conversations. That’s an important metric for patients and their caregivers, as it can help more people live as independently as possible for as long as possible as the disease progresses.

Treating Alzheimer’s Very Early Offers Better Hope of Slowing Decline...

A trial of donanemab, an experimental drug, found it modestly slowed the worsening of memory and thinking and worked better in patients at earlier stages and those under 75.

What impact will Alzheimer’s drug donanemab have?

While it is not a cure, proof that drugs can alter course of disease is regarded as significant triumph.

Resources

AlzForum

Donanemab, aka N3pG, is a humanized IgG1 monoclonal antibody developed from mouse mE8-IgG2a. This biologic drug recognizes Aβ(p3-42), a pyroglutamate form of Aβ that is aggregated in amyloid plaques.