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Dementia Australia has welcomed the news that the pharmaceutical companies behind the development of aducanumab, an investigational treatment for the early stages of Alzheimer’s disease, would pursue regulatory approval for the drug.
Dementia Australia CEO Maree McCabe said the news for a future study of aducanumab following the discontinuation of global clinical trials earlier this year, was an exciting development, especially for the approximately 100 Australian trial participants who would be given the opportunity to restart taking the drug.
“This announcement provides real hope for future treatments and more importantly we hope globally, that more researchers and investors are inspired to get involved with dementia research that will potentially make a difference to lives of the tens of millions of people around the world impacted by dementia,” Ms McCabe said.
Aducanumab includes antibodies designed to attach to and remove amyloid plaques.
According to Biogen, the company conducting the research, the interim analyses of trials initially indicated that it was unlikely that the drug would show significant clinical benefit.
More recently, additional data from these studies became available resulting in a larger dataset, including results from participants that had the opportunity to complete the full 18 months of treatment.
The results showed that trial participants treated with high dose aducanumab showed a significant reduction of clinical decline from baseline compared to those receiving placebo at 78 weeks follow-up.
Those who received aducanumab experienced benefits on measures of cognition and function such as memory, orientation and language. Participants also experienced benefits with activities of daily living including managing personal finances, performing household chores such as cleaning, shopping, laundry and independently travelling out of the home.
The imaging of amyloid plaque deposition demonstrated that amyloid plaque burden was reduced with low and high dose aducanumab compared to placebo at 26 and 78 weeks.
Dementia Australia Honorary Medical Advisor Assoc Prof Michael Woodward AM said the revival of the study was promising.
“This is an amazing paradigm shift – over the years there have been many new developments in research, however, I feel really confident that we are very close to a breakthrough,” Assoc Prof Woodward said.
The next step for Biogen will be to submit an application to the US Food and Drug Administration in early 2020. The clinical trial for this drug is not open to new patients at present.
More information will be available at 12th Clinical Trials on Alzheimer's Disease Conference in December in San Diego, USA and at Alzheimer’s Disease International’s 34th International Conference in Singapore in March 2020.
Dementia Australia is the national peak body and charity for people, of all ages, living with all forms of dementia, their families and carers. It provides advocacy, support services, education and information. An estimated 447,000 people have dementia in Australia. This number is projected to reach almost 1.1 million by 2058. Dementia Australia is the new voice of Alzheimer’s Australia. Dementia Australia’s services are supported by the Australian Government.
National Dementia Helpline 1800 100 500
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(The National Dementia Helpline is an Australian Government Initiative)
Dementia is a National Health Priority Area www.dementia.org.au
Media contacts: Sarah Richards, Media & Communications Advisor, 0448 341 628, [email protected] / Dr Fiona Wade, Manager, Media & Communications, 0407 019 430, [email protected]
When talking or writing about dementia please refer to Dementia-Friendly Language Guidelines.
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