Breakthrough results in a Phase 3 trial for Alzheimer’s drug treatment Lecanemab has given hope to millions of people living with the disease.

Over the past three decades, Alzheimer’s research has generally focussed on the removal of amyloid clumps, called ‘plaques’—a hallmark of Alzheimer’s disease—with little success to date.

Now, highly anticipated data from Eisai Co. and partner Biogen Inc’s global clinical study shows treatment with amyloid-clearing antibody Lecanemab is not only effective at clearing amyloid but slows the pace of cognitive decline by 27%. Symptomatic side effects were seen in 3-4% of those given the drug that is administered by injection once a fortnight.

The Australian Dementia Network (ADNeT), led by the University of Melbourne, is a national network of leading dementia experts working towards prevention, treatment and better care for dementia. ADNeT works with pharma companies on clinical trials and assisted Eisai with the Clarity study in Australia. ADNeT experts have welcomed the milestone findings.

Professor Christopher Rowe, ADNeT Director believes the Lecanemab results are exciting.

“They confirm that treatments that remove amyloid are on the right path and have a real benefit when given to people with established symptoms of Alzheimer’s disease, the leading cause of dementia in Australia.”

“ADNeT is also working with Eisai to delay or prevent dementia due to Alzheimer’s disease by giving Lecanemab to persons with brain amyloid detected by PET scan before they develop symptoms. This study is called AHEAD and is currently looking for participants in Australia, the USA and Japan,” he said.

Professor Colin Masters, ADNeT Screening and Trials Lead, whose work is widely acknowledged as having had a major influence on Alzheimer’s disease worldwide said Lecanemab is one of several first-in-class disease modifying drugs for Alzheimer’s disease.

“It has been 25 years since Eisai launched a symptomatic therapy, Aricept, and now for the first time we can clearly see the way forward for true disease modification. There is a strong expectation that these novel antibodies will be more effective in the earliest stages of Alzheimer’s disease, particularly in the preclinical stage, before any symptoms are present,” he said.

“We are now actively recruiting for participants to join in clinical trials at the earliest preclinical stage, particularly people who are at increased risk because of their family histories of dementia.”

Over 1700 participants were recruited to the CLARITY study worldwide including in Australia.

Dr Paul Yates is the Deputy Director of Aged Care Research at Austin Health and lead Principal Investigator for the CLARITY and AHEAD studies in Australia. He notes that the success of the CLARITY study was particularly noteworthy, given the challenges faced during the pandemic.

“Our participants tell us that they have really enjoyed participation in the Study, and they are keen to continue.”

Currently, ADNeT is recruiting participants for Eisai’s AHEAD Study and other preventative studies. Similar drug therapies targeting the same amyloid beta pathway, namely Roche’s Gantenerumab and Eli-Lilly’s Donanemab, are hopeful of similar positive results from Phase 3 trials in the coming months based on their Phase II trials, with all three companies expected to seek accelerated approval from the American Food and Drug Administration in early 2023. The Eisai trial result also supports the positive but controversial findings of the Biogen aducanumab phase III trials.

“This is not a cure but it is a vital first step towards prevention, treatment and cure of dementia” said ADNeT Director Professor Christopher Rowe.

“On-going research is vital to see if the benefit from this drug increases with time or by earlier use in the disease, and to develop additional treatments that increase the benefit to individuals”.

An estimated 500,000 Australians are living with dementia today and it is the leading cause of death in women and the second leading cause of disease burden and death in Australians over the age of 65 years.

Alzheimer’s disease is the major cause of dementia in Australia. These pioneering results mark a promising and long-awaited development in what has been a slow journey towards effective treatments urgently needed to tackle the dementia epidemic in Australia and worldwide.

Professor Rowe recently spoke on 3AW Breakfast about the Lecanemab results. You can listen to the interview here.

If you are interested in taking part in studies for dementia, please sign up to our ADNeT volunteer registry. https://www.australiandementianetwork.org.au/i-am-a-member-of-the-public-or-consumer/volunteer-for-trials/