Will the new Alzheimer’s drug stave off brain decline?

Can the tide finally turn in the search for an effective treatment for Alzheimer’s disease? That was the suggestion of a story last week about a new drug, lecanemab, which appears to improve the symptoms of early Alzheimer’s.

For decades, researchers have been working on drugs to treat the condition without much success, so understandably there was excitement after the pharmaceutical companies behind lecanemab – Eisai and Biogen – announced that it slowed early Alzheimer’s, particularly cognitive decline, by 27 percent over 18 .months in a trial of 1,795 people.

But while this was hailed as a “historic moment”, the trial data is not yet available for independent review – and past experience with similar drugs suggests we should be cautious.

The preliminary lecanemab data are unique in that they show that the drug can slow disease progression

Last year, Good Health reported on aducanumab, the first new Alzheimer’s drug in two decades to be approved by the US regulator, the Food and Drug Administration (FDA).

The approval was controversial because, despite removing plaque in the brain (seen as a hallmark of Alzheimer’s), the drug did not significantly improve symptoms.

In addition, more than 35 percent of trial participants experienced brain side effects, including swelling, reported a study in the journal JAMA Neurology earlier this year that analyzed data from a number of trials.

There are also ongoing studies of a very small number of patients who died after taking aducanumab. Lecanemab works in the same way as aducanumab (but appears to target a slightly different type of amyloid) – and the preliminary data suggests that the rate of side effects, such as swelling or bleeding in the brain, was 21.3 percent in the lecanemab- group and 9.3 percent in the placebo group; something the developers described as ‘within expectations’.

Both aducanumab and lecanemab clear the brain of plaque, formed by a build-up of a sticky protein called amyloid – this has been linked to dying nerve cells.

Until now, most drugs that target amyloid, including aducanumab, have not led to a clinical benefit, ie. improved brain function or memory.

The preliminary lecanemab data are unique in that they show that the drug can slow disease progression.

However, some experts have said the drug’s ability to slow cognitive decline is modest, and it’s not yet clear whether patients will find it meaningful.

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The approval was controversial because, despite removing plaque in the brain (seen as a hallmark of Alzheimer’s), the drug did not significantly improve symptoms.

In the trial, the difference between people given the drug and those given a placebo was 0.45 points on the 18-point clinical dementia scale, which measures memory and cognitive ability.

As one expert commented: ‘The accepted minimum difference varies from 0.5 to 1.0 points.’

There are other challenges, such as convenience – it is given as a fortnightly infusion; although a simpler injection of lecanemab is also being tested in early trials.

The developers say the trial results will be presented at a conference on November 29 and published in a peer-reviewed journal, with plans to file for approval in the US, Japan and Europe next March.

But like aducanumab, lecanemab has been given fast-track status by the FDA, which could see it approved in the US in January.

It is clear that there is great interest in a cure for dementia – but what is not clear is whether we are one step closer to the Holy Grail.

What the experts say

Professor Tara Spiers-Jones, group leader at the UK Dementia Research Institute at Edinburgh University, said: ‘If the data holds up to scrutiny, this is fantastic news indeed. Although this is not a “cure” because it does not return people to normal, it would still be a huge gain to slow cognitive decline and maintain the ability to perform daily activities.’

Dr. Charles Marshall, an honorary consultant neurologist at Queen Mary University of London: “The benefits are quite small and must be weighed against the risk of side effects, including inflammation and bleeding in the brain.”

Peter Passmore, Professor of Aging and Geriatric Medicine at Queen’s University Belfast:'[clinIcal benefits] appear to be small, and the debate will be about how clinically relevant the changes are.’

Masud Husain, professor of neurology at Oxford University: “Although the summary of the results seems very encouraging, we must be cautious until we are allowed to review the data in full. It is also important to remember that the trial results only apply to people with mild Alzheimer’s disease . . . and that there were important side effects.’

Rob Howard, professor of geriatric psychiatry at University College London:

‘This is an unequivocally statistically positive result and represents something of a historic moment.’

Jacky

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