Experts Declare Imminent Availability of Alzheimer’s Drugs, Marking a Remarkable Shift from Previous Perceptions

Donanemab, a drug developed by Eli Lilly, has demonstrated a significant 33% reduction in the progression of Alzheimer’s disease, prompting experts to describe the current stage as being “on the cusp” of groundbreaking treatments, an outcome that was deemed “impossible” not long ago.

Regrettably, three individuals, including two volunteers, experienced fatal brain swelling as an adverse effect of the drug.

Viscous Residue

Donanemab operates under a similar mechanism as lecanemab, which garnered global attention for its demonstrated ability to decelerate the progression of the disease.

Both drugs belong to the class of antibodies, resembling those naturally produced by the body to combat viruses. However, these antibodies are specifically engineered to eliminate a substance known as beta-amyloid, which accumulates as a sticky residue within the brain.

The build-up of amyloid within the intercellular spaces leads to the formation of distinct plaques, recognized as a prominent characteristic of Alzheimer’s disease.

“The decades-long battle to find treatments that change Alzheimer’s disease is changing,” Dr. Cath Mummery, the clinical lead for the cognitive disorders clinic at the UK’s National Hospital for Neurology and Neurosurgery, said.

“We are now entering the time of disease modification, where we might realistically hope to treat and maintain someone with Alzheimer’s disease, with long-term disease management rather than palliative and supportive care.”

The comprehensive publication of Eli Lilly’s trial data is still pending; however, key findings have been disclosed:

• A total of 1,734 individuals in the initial stages of Alzheimer’s participated in the study.

• Donanemab was administered as a monthly infusion until the distinctive brain plaques associated with the disease were eradicated.

• Overall, the pace of disease progression was reduced by approximately 29%. Notably, in a subgroup of patients deemed more likely to respond, the disease’s progression was slowed by 35%.

• Patients receiving the drug also exhibited better preservation of their day-to-day lives, such as engaging in discussions about current events, driving, and pursuing hobbies.

However, brain swelling emerged as a common side effect, affecting up to one-third of the patients.

In most cases, the swelling was mild or asymptomatic, detected only through brain scans. Nevertheless, 1.6% of participants experienced dangerous brain swelling, leading to two direct fatalities, while a third volunteer passed away after encountering such an occurrence.

“We are encouraged by the potential clinical benefits that donanemab may provide, although, like many effective treatments for debilitating and fatal diseases, there are associated risks that may be serious and life-threatening,” Eli Lilly group vice-president of neuroscience research and development Dr. Mark Mintun said.

The company said it would begin having its drug approved for use in hospitals in the next few months.

Dr. Liz Coulthard, from the University of Bristol, said there were “significant side-effects” and a lack of long-term data but the drug could “help people live well with Alzheimer’s for longer”.

‘Thought Impossible’

Having two drugs slow the disease by targeting amyloid in the brain has also convinced scientists they are on the right track after decades of misery and failure.

“This should dispel any lingering doubts about this approach,” Prof John Hardy, from the UK Dementia Research Institute, whose work led to the idea of targeting amyloid, 30 years ago, said. “Having two drugs is great for competition.”

Dr. Susan Kolhaas, from Alzheimer’s Research UK, said: “We’re now on the cusp of a first generation of treatments for Alzheimer’s disease, something that many thought impossible only a decade ago.”

However, these drugs appear to work in only the earliest stages of the disease – before the brain is too damaged.

And if they are approved in the UK, it would still take a revolution in how the disease is diagnosed to make a difference.

Only 1-2% of people have either brain scans or a spinal-fluid analysis to determine whether they actually have Alzheimer’s or another form of dementia against which the drugs would be useless.

And the NHS would have to decide whether it could afford them. Lecanemab costs more than £21,000 per person per year.

SOURCE: BBC