First drug to slow Alzheimer’s Disease unveiled in landmark breakthrough
Solanezumab is the first drug shown to target the disease process itself, clearing sticky plaques in the brain which stop the neurons firing
The first drug which slows down Alzheimer's disease could be available within three years after trials showed that it prevented mental decline by a third.
In a landmark announcement, pharmaceutical giant Eli Lilly said that solanezumab has been shown to put the brakes on the disease for people with mild symptoms.
It is the first time that drug has been shown to work on the underlying disease process itself rather than the symptoms, slowing decline in memory and thinking skills.
Although trials are continuing and will not end until next year, the treatment could be available for use by 2018 if approved by the Medicines & Healthcare products Regulatory Agency (MHRA) and The National Institute for Health and Care Excellece (NICE).
Health experts in the UK said the research demonstrated a 'huge step forward from the current treatment options' while charities hailed the announcement as 'exciting.'
Prof Richard Morris, Professor of Neuroscience, University of Edinburgh, said the announcement was ‘significant.’
“This is not a mouse study, it’s a people study. And that matters,” he added.
Alzheimer’s Disease is caused when sticky amyloid plaques form in the brain preventing neurons from communicating with each other.
Solanezumab is an antibody which binds to amyloid in its early soluble form allowing it to be cleared by the body before it can form dangerous plaques.
The drug was originally developed for people with late-stage dementia but was found to be ineffective. However researchers noticed that it was having an impact on people with mild symptoms. The breakthrough is significant because tests are in development which could pick up Alzheimer’s 10 years before the first symptoms emerge, meaning that treatment could start very early and perhaps prevent the plaques ever forming.
The trial followed 1,322 people with mild Alzheimer’s disease for three and a half years. Cognitive tests showed that the mental decline of those taking the drug was a third less over the period than those on placebo.
“The results provide encouraging evidence that solanezumab could indeed be acting on the disease processes that drive Alzheimer’s," said Dr Eric Karran Director of Research at Alzheimer’s Research UK.
“Although this effect represents a small improvement for people experiencing mild symptoms, it will be important for longer trials to explore whether this treatment could produce greater benefits in the long-term.
“While this could be evidence of the first disease-modifying treatment for Alzheimer’s, the ultimate test will be whether these promising effects repeat again in the third, more targeted, phase III trial in people with mild Alzheimer’s due to finish late next year. We await the results of that trial with great interest.”
Around 850,000 people in the UK have a form of dementia. In less than 10 years, 1 million people will be living with the condition. This is expected to soar to 2 million by 2051.
Around 225,000 people will develop dementia in the UK this year, a rate of one person every three minutes.
Dr Doug Brown, Alzheimer’s Society’s Head of Research said: “Today’s findings strongly suggest that targeting people in the earliest stages of Alzheimer’s disease with these antibody treatments is the best way to slow or stop Alzheimer’s disease.
“These drugs are able to reduce the sticky plaques of amyloid that build up in the brain, and now we have seen the first hints that doing this early enough may slow disease progression.
“After a decade of no new therapies for dementia, today’s news is an exciting step forward.
We will have to wait for the ongoing trials to finish to know the full risks and benefits of these drugs. If they are positive, these drugs will be the first identified to directly interfere with the disease process and slow the progression of Alzheimer’s.”
Dr Tara Spires-Jones, Chancellor’s Fellow and Reader, Centre for Cognitive and Neural Systems, University of Edinburgh, said: "If it proves to be disease modifying in the current phase 3 trial and provides long term benefits, it will be a huge step forward from the current treatment options."
Prof Morris, Professor of Neuroscience, University of Edinburgh, said that trial proved that researchers were right to believe that amyloid plaques were driving dementia and preventing them forming was the key to slowing or stopping the disease.
“My own judgement is that it is likely to be significant," he said.
“My grounds for suspecting significance is that the new study constitutes positive evidence for the amyloid hypothesis that has been around for over 20 years.
“Many have been anywhere from sceptical to downright dismissive of the idea given the sheer number of failures of antibody studies.”
Results released today also showed that two other drugs Gantanerumab and Aducanumab were effective at reducing biomarkers for Alzheimer's disease and offered early hope of new treatments.
The research was presented at the Alzheimer's Association International Conference in Washington, US.