11 months ago
94 Health
The experimental attraction donanemab is present the 2nd antibody cause to dilatory cognitive diminution successful radical with aboriginal signifier Alzheimer’s disease, but questions stay astir its real-world benefits and safety
By Alice Klein
Plaques of the macromolecule amyloid physique up successful the brains of radical with Alzheimer’s disease
nobeastsofierce Science/Alamy
A cause called donanemab has been shown to dilatory cognitive diminution by 35 per cent successful radical with aboriginal Alzheimer’s disease. However, determination has been a mixed absorption arsenic to however large of an interaction this slowed diminution volition person connected a idiosyncratic with Alzheimer’s beingness and immoderate are acrophobic implicit the hazard of superior encephalon swelling and bleeds.
Donanemab is an antibody attraction that is being developed by US pharmaceutical institution Lilly. It binds to clumps of macromolecule called amyloid plaques that physique up successful the brains of radical with Alzheimer’s disease. This binding activates an immune effect to wide them out.
The cause was evaluated successful a clinical trial involving astir 1200 radical aged 60 to 85 with aboriginal Alzheimer’s disease – defined arsenic mild cognitive impairment and dementia owed to the information – successful the US, Canada, UK, Australia, Japan and Europe. The participants received intravenous injections of donanemab oregon a placebo each 2 weeks implicit 18 months.
At the opening and extremity of the trial, the participants were assessed connected their cognitive skills and quality to sermon existent events, negociate their finances and behaviour different mundane tasks.
Those taking donanemab had 35 per cent slower diminution successful their wide scores than those successful the placebo group, according to a results summary released by Lilly connected 3 May.
“The results of this survey are precise encouraging,” says Bruce Brew astatine the University of New South Wales, Australia. “While the afloat results are yet to beryllium published, the information that person been released amusement it importantly slows progression of Alzheimer’s.”
Matthew Schrag astatine Vanderbilt University, Tennessee, has said that portion the 35 per cent diminution is simply a statistically beardown effect, it whitethorn not beryllium clinically relevant. “It doesn’t springiness radical their representation back,” helium tweeted.
In a statement, Susan Kohlhaas astatine Alzheimer’s Research UK said the “treatment effect is modest”, but we are “on the cusp” of caller therapies for the condition.
Donanemab has information concerns, with brain swelling occurring successful 24 per cent of those who received the drug. This broadside effect was not reported among those successful the placebo group. Brain bleeds affected 31 per cent of those connected donanemab, compared with 13 per cent successful the placebo group. These resolved with due absorption successful astir cases, but 3 participants died.
“There are risks of superior broadside effects that request to beryllium afloat scrutinised earlier donanemab tin beryllium marketed and used,” says Kohlhaas.
In November, different experimental amyloid-clearing antibody attraction called lecanemab, developed by Japanese institution Eisai, was reported to slow cognitive diminution by 27 per cent successful radical with aboriginal Alzheimer’s illness implicit 18 months. It, too, was associated with encephalon swelling and bleeding successful immoderate people. It was approved by the US Food and Drug Administration (FDA) successful January.
Another amyloid-clearing antibody attraction for Alzheimer’s illness is besides connected the market: aducanumab, which was approved by the FDA successful 2021. However, it has only been shown to wide amyloid from the brain rather than improving Alzheimer’s symptoms.
Lilly has said it volition use for regulatory support for donanemab from the FDA this fiscal quarter.
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