There is finally a glimmer of hope in the fight against Alzheimer’s, the most common form of dementia, which affects memory, language and thought.
Drug maker Lilly has announced that its experimental drug donanemab slowed cognitive decline by 32 per cent in patients with early Alzheimer’s in a clinical trial over a two-year period.
Experts welcomed the news, but cautioned that the study was small, that more complete data needed to be available and that the findings needed to be replicated.
Lilly is already undertaking a second trial and says it will publish its complete dataset in a medical journal and present it for consideration at an upcoming medical conference.
“We are extremely pleased about these positive findings for donanemab as a potential therapy for people living with Alzheimer’s disease, the only leading cause of death without a treatment that slows disease progression,” said Mark Mintun, vice-president of pain and neurodegeneration, Eli Lilly.
“We look forward to discussing the TRAILBLAZER-ALZ study data and next steps with global regulators. In addition, we are committed to reproducing and extending these important findings in our second ongoing pivotal donanemab trial, TRAILBLAZER-ALZ 2,” he added.
Dr Daniel Skovronsky, Lilly’s chief scientific officer, said in a prepared statement: “The positive results we have obtained today give us confidence in donanemab and support its rapid and deep plaque clearance for the potential treatment of Alzheimer’s disease.”
He said Lilly’s drug had the potential to provide “high levels of durable amyloid plaque clearance after limited duration dosing”.
“This allowed us to conduct a trial to test if reducing amyloid plaques in Alzheimer’s patients to levels seen in scans of healthy individuals could result in clinically meaningful slowing of cognitive decline.”
Beta-amyloid plaque is a “microscopic brain protein fragment … a sticky compound that accumulates in the brain, disrupting communication between brain cells and eventually killing them”.
Researchers such as Lilly believe “flaws in the processes governing production, accumulation or disposal of beta-amyloid are the primary cause of Alzheimer’s”.
Bloomberg reports that donanemab “differs from other, similar drugs in that it is aimed at removing amyloid that has already been deposited in the brain”.
“Many other experimental medications have aimed to block soluble forms of the protein that have yet to be deposited.”
It’s a rarity with Alzheimer’s to get a trial with such clear-cut positive results, Dr Skovronsky told Bloomberg. It is “unusual if not unique in Alzheimer’s disease” to have a study that meets its main efficacy goal on the full set of patients.
Analysts disagreed on whether the Lilly trial is a positive for rival Biogen, whose drug aducanumab is awaiting an approval by the US Food and Drug Administration (FDA) by 7 March. That drug operates on the same ‘amyloid hypothesis’, but in November, an FDA advisory committee voted 10 to one against its approval, saying the clinical data backing the drug was inconclusive.
The New Daily quoted analysts from the Mizuho Financial Group:
“Our expert found the results fairly encouraging and sees a higher likelihood of success for donanemab relative to other antibodies at comparative stages of their development.
“However, given the disappointing history of the amyloid beta approach to date, our expert remained cautious in his outlook overall and believes donanemab’s probability of clinical success is still less than 50 per cent.”
Alzheimer’s disease (Healthline)
Dementia is the term applied to a group of symptoms that negatively affect memory, but Alzheimer’s is a progressive disease of the brain that slowly causes impairment in memory and cognitive function. The exact cause is unknown, and no cure is available.
- difficulty remembering recent events or conversations
- impaired judgement
- behavioural changes
- difficulty speaking, swallowing, or walking in advanced stages of the disease.
No cure for Alzheimer’s is available, but options to help manage symptoms of the disease include:
- medications for behavioural changes, such as antipsychotics
- medications for memory loss, which include cholinesterase inhibitors donepezil (Aricept) and rivastigmine (Exelon) and memantine (Namenda)
- alternative remedies that aim to boost brain function or overall health, such as coconut oil or fish oil
- medications for sleep changes
- medications for depression.
Do you think a cure for Alzheimer’s disease is coming soon?
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