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Alzheimer’s drug results are promising – but let’s not get carried away

Published

1 year ago

21 October 2022

JeffG

Alzheimer’s drug results are promising – but let’s not get carried away

UNSW Sydney

Clinical trial results for lecanemab are a significant step rather than a ‘historic breakthrough’, say UNSW Alzheimer’s experts.

Partner companies Eisai and Biogen have recently announced promising clinical trial results for their new Alzheimer’s drug lecanemab. Over 18 months, patients treated with lecanemab experienced slower symptom progression than the placebo group. These results have been described as a ‘historic moment for dementia research’ – but what do they really mean for patients?

Alzheimer’s is a degenerative brain disease that leads to dementia – a decline in memory, reasoning and other thinking skills. Disease progression can initially be very slow, with changes in the brain occurring up to 25 years before symptoms arise. However, once these cognitive issues are present, living with Alzheimer’s can be very challenging for patients and their families.

Alzheimer’s has puzzled scientists for decades

There is some contention around what alterations in the brain drive Alzheimer’s disease, with several culprits identified so far.

“What actually causes Alzheimer’s disease is not really known… There’s some debate about how and when these processes happen,” says Scientia Professor Henry Brodaty AO, Co-Director of the Centre for Healthy Brain Ageing (CHeBA) at UNSW Sydney.

One of the prime suspects is a protein fragment called beta-amyloid, which is quite sticky and can accumulate in clumps in the brain, called ‘amyloid plaques’. These clumps of protein build up around neurons – the brain cells that power thinking. The ‘amyloid hypothesis’ is a theory that amyloid plaques are the first step in the development of the disease.

Amyloid is directly toxic to brain cells, and also promotes the development of the other main brain pathology – neurofibrillary tangles in brain cells. The tangles are made of tau proteins that get knotted up inside neurons, blocking function and causing toxicity. Plaques also lead to the development of inflammation in the brain which is harmful to brain cells.

Limited treatments are available for Alzheimer’s

Most of the current Alzheimer’s drugs help to manage symptoms but can’t halt or reverse brain degeneration. They mainly work by maintaining levels of neurotransmitters – brain chemicals that neurons use to communicate with one another – which can be decreased in patients with Alzheimer’s.

“Research into Alzheimer’s treatments in the ’80s came up with the only current drugs on the market,” says Professor Peter Schofield AO, the CEO of Neuroscience Research Australia (NeuRA) and professor at UNSW Medicine & Health.

“The existing drugs only target symptoms and provide a delay in disease progression. They’re not targeting the underlying disease cause.”

Treatments that target the underlying causes of a disease are referred to as disease-modifying. The drug aducanumab, which was also developed by Eisai and Biogen, is the only disease-modifying treatment that has been approved for Alzheimer’s. Aducanumab, marketed as Aduhelm, is an antibody that targets amyloid plaques and helps the immune system to clear them from the brain.

In 2021, aducanumab was approved for use in the US by the Food and Drug Administration (FDA) but it isn’t approved in other countries, including Australia and Europe. The FDA approval was highly controversial as clinical trials had failed to show that the drug caused an improvement in dementia symptoms, although the drug did clear amyloid plaques. Aducanumab treatment also led to a degree of brain swelling and/or bleeding in up to 40 per cent of clinical trial participants.

Lecanemab’s clinical trial results

Lecanemab is a new drug that works similarly to aducanumab – an antibody that promotes clearing of beta-amyloid from the brain. However, lecanemab targets amyloid fibrils, which are smaller clumps of protein that eventually turn into amyloid plaques.

“Lecanemab is designed a little bit differently. It’s trying to remove the amyloid fibrils,” says Professor Schofield. “Why wait until you’ve got a pile of garbage – the plaque? Why don’t you just pick up bits of litter on the way?”

Eisai and Biogen reported that in their latest 18-month clinical trial, symptom scores for patients treated with lecanemab had worsened 27 per cent less compared to those given a placebo. This has been met with much excitement as, unlike aducanumab and other previous treatments, lecanemab has shown the first evidence of slowing down Alzheimer’s progression.

At the same time, the limitations of these results can’t be ignored.

“These results provide a glimmer of hope in a field in which numerous previous trials have failed to achieve their primary outcomes,” says Scientia Professor Perminder Sachdev, Co-Director of CHeBA and Clinical Director of the Neuropsychiatric Institute of the Prince of Wales Hospital. “Whether this result is clinically meaningful is, however, still uncertain.”

Firstly, though statistically significant, the difference in symptoms between the treatment and placebo group in the trial was 0.45 points on an 18-point scale. Most clinicians in the field suggest that a greater difference is needed to impact patients’ lives, for example 1 to 2 points.

Secondly, lecanemab targets beta-amyloid build up but there are probably other contributors to Alzheimer’s progression – for example neurofibrillary tangles. These other changes would not be fixed with this drug.

It also must be acknowledged that, like aducanumab, lecanemab causes the potentially serious side effects of brain swelling and bleeding. In this recent clinical trial, 21 per cent of the treatment group versus 9 per cent of the placebo group experienced these changes on brain MRI scan.

Finally, Alzheimer’s disease is only one of many causes of dementia, so lecanemab won’t be of benefit to those with other causes, for example vascular changes and Parkinson’s disease. In very old people with more severe dementia, there are often multiple contributing factors. The lecanemab trial did not focus on this patient group – the drug’s impact was only tested in those with early or mild dementia caused by Alzheimer’s.

Not a breakthrough, but a positive step

Despite all these caveats, these latest findings are a significant step forward for Alzheimer’s research. Lecanemab is the first-ever treatment that slows down symptom progression, even if the effect is small.

“We still have a long way to go until we have what everyone wants. A treatment for Alzheimer’s for themselves, their loved one, their parent, that is affordable and efficacious,” says Professor Schofield. “But it looks like we’ve got a first foot on the ladder.”

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Specialist mental health service for new parents opens in Lismore

Published

2 weeks ago

22 November 2023

Liam

CEO Gidget Foundation Australia Arabella Gibson, NSW Minister for Mental Health Rose Jackson, Lismore MP Janelle Saffin, Gidget Angel Kaiden Powell and Tresillian operations manager Rachael McLean at the opening of Gidget House in Lismore.

Specialist mental health service for new parents opens in Lismore

By Sarah Waters

New and expecting parents in the Northern Rivers will now have access to free specialised mental health care as they navigate their journey through parenthood.

Last Friday, Gidget House officially opened at Tresillian Lismore Family Care Centre to support parents struggling with perinatal depression and anxiety.

Gidget House provides year-long, free individual psychological counselling services and holistic care delivered face-to face and via telehealth.

New data from Gidget Foundation Australia reveals one in two parents living in regional NSW lack both emotional and practical support from their family and friends.

A quarter of parents in regional NSW also needed the most support between 3-12 months after the birth of their child.

While one in three felt a loss of identity in most aspects of their life after having a baby.

NSW Minister for Mental Health Rose Jackson officially opened Gidget House and welcomed the service for expectant and new parents to the area.

CEO Gidget Foundation Australia Arabella Gibson, NSW Minister for Mental Health Rose Jackson, Lismore MP Janelle Saffin, Gidget Angel Kaiden Powell and Tresillian operations manager Rachael McLean at the opening of Gidget House in Lismore.

Ms Jackson said families across the Northern Rivers had experienced unparalleled challenges over recent years with floods and threats of fires, whilst still navigating adjusting to early parenthood.

“This is why providing mental health support in regional communities such as Lismore and the surrounds is a top priority of ours,” she said.

“It’s important for expectant and new parents to have access to quality services like Gidget Foundation Australia in times of need and know that help is never too far away.”

Gidget Foundation Australia CEO Arabella Gibson said the expansion of face-to-face services across the state will provide much needed support for parents in regional locations.

“With half of parents in regional NSW reporting a lack of emotional and practical support after having a baby, it’s necessary for us to expand our services to reach more mums and dads who may be struggling,” Ms Gibson said.

“As part of our valued commitment to support the emotional wellbeing of expectant and new parents across the country, we’re hopeful our expansion to Lismore will provide a safe space for open conversations with perinatal specialist clinicians.”

It is estimated that perinatal depression and anxiety affect almost 100,000 expectant and new parents in Australia each year.

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Health News

Virtual reality is helping brain injury survivors regain use of their arms and hands

Published

2 weeks ago

22 November 2023

Liam

Neuromersiv has created the Ulysses VR Upper Limb Therapy System Virtual reality (VR) to help people come back from brian ijuries.

Virtual reality is helping brain injury survivors regain use of their arms and hands

Survivors of brain injuries caused by stroke and other serious events can lose function in their arms and hands. An Australian company is creating a virtual reality therapy system to help survivors regain the use of these limbs.

Making brain injury therapy more engaging

Getting better after brain injury is hard work. Survivors need therapy to help the brain to heal. But therapy can be boring and repetitive. This means survivors don’t always do as much therapy as they need.

To make therapy more engaging, Australian company Neuromersiv has created the Ulysses VR Upper Limb Therapy System. Using a wireless virtual reality (VR) headset, brain injury survivors can do therapy by performing rewards-based, gamified activities in realistic environments.

An immersive environment

‘As soon as the person puts on the headset, they are totally immersed,’ CEO Anshul Dayal enthuses. ‘Like with gamers, dopamine kicks in and they want to keep going. So VR creates the motivation to keep doing your therapy. That can lead to better function recovery.’

The Ulysses VR software is available to buy in Australia and Britain. ‘I am proud we’ve taken this to market. We’re seeing people use it and give us positive feedback,’ Anshul says.

Wearable glove

As part of the Ulysses therapy system, Neuromersiv has also developed a hand and arm wearable glove. The glove helps users activate their muscles and receive real-time sensory feedback from VR environments. It combines two therapy modes with the VR software.

Functional electrical stimulation (FES) therapy helps brain injury survivors activate muscles they can’t move. Electrodes in the glove send small electrical currents through key points on the forearm muscles to stimulate extension and flexion.

New neural pathways

‘If the survivor is trying to brush their teeth in virtual reality but they just can’t grab the virtual toothbrush, the FES can assist with the grabbing action by stimulating flexion of the wrist and fingers,’ Anshul explains.

‘This stimulation creates a feedback loop that can be a catalyst for the brain to form new neural pathways to recover lost function. This is often referred to as brain neuroplasticity and is the key to long-term functional recovery.’

To make therapy more engaging, Australian company Neuromersiv has created the Ulysses VR Upper Limb Therapy System.

Sensory feedback

The team is also combining tactile feedback, or haptics, with the glove. For example, when users brush their teeth in virtual reality, they get a vibration effect on their fingers.

‘The goal is to enhance the sensory feedback because that helps the brain start to recognise the end of the fingertips, Anshul tells us. ‘When the person stops doing that task, they still feel tingling on the fingertips. That helps reactivate those neural connections.’

‘We are building a system that has multiple layers. Combining the visual and sensory aspects could improve functional recovery,’ Anshul concludes.

‘We think we are the first company in the world to combine FES, haptics and virtual reality.’

Technical challenges

The team had to overcome technical challenges to achieve this. Cameras on the virtual reality headset track users’ hands as they do therapy. The team’s first prototype had an exoskeleton design that impeded the hand tracking and overall usability. This was refined through user testing and design modifications.

‘For the FES, we created a sleeve with adjustable electrodes to wrap on the forearm,’ Anshul says. ‘For the haptics, we created a unique system of finger caps connected by soft & thin wires. It goes on top of the hand and doesn’t interfere with the tracking.

‘The next challenge was creating a wireless control unit for the glove that was compact and lightweight.’

Approval to sell the glove in Australia

Neuromersiv is planning a pivotal clinical trial to develop further clinical evidence on the safety and efficacy of the glove. With this evidence they will seek regulatory approval from the Therapeutic Goods Administration to commercialise the glove in Australia.

‘When you work with people in their homes and clinics, it can be confronting see the challenges they can face after the brain injury. That inspires me to help people through this Ulysses solution,’ Anshul says.

‘I have seen proof that when they use the system, they feel motivated and excited. They feel this can really help their therapy, and that’s quite rewarding.’

The MRFF-funded MTPConnect Biomedtech Horizons program funded Ulysses with $994,000.

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Health News

Think Twice About Asbestos

Published

2 weeks ago

22 November 2023

Liam

asbestos in a roof. National Asbestos Awareness week

Think Twice About Asbestos

It’s easy to forget that asbestos is still present in millions of Australian properties, but it’s a fact, that if a house was built or renovated before 1990, there’s a good chance it contains asbestos.

“National Asbestos Awareness week (20 -26 Nov) is a good opportunity to remind everyone to ‘Think Twice About Asbestos’ when planning any renovations, repairs or other work on buildings that may contain asbestos” said Karen Rudkin, Project Coordinator at North East Waste.

“Although many people know that asbestos cement sheeting was used for walls and roofs they often don’t realise that asbestos was used in thousands of other building products including vinyl floor tiles, adhesives, paints, textured coatings and insulation’ Ms Rudkin said.

North East Waste and councils across the Northern Rivers are working together with the NSW Environmental Protection Authority to help reduce the risk of exposure to asbestos by supporting the safe management and disposal of asbestos containing materials.

To keep yourself and your family safe around asbestos, take these simple steps:

Get in the know – plan ahead before starting any renovations and find out where asbestos is likely to be in your home.
Take it slow – to avoid damaging or disturbing asbestos materials.
Get a pro – know your limits. Contact a licensed asbestos professional for advice on where it might be located, and on how to manage or remove it.

As part of a regional scheme aimed at reducing the unsafe disturbance or removal of asbestos by home renovators, all Northern Rivers councils offer subsidised ‘Household Asbestos Testing’ (HAT) kits.

The kits include easy step-by-step instructions on how to take samples safely and send to a certified testing laboratory. The results are then emailed back to residents. If asbestos is identified and requires removal, residents are urged to use a licensed removal contractor to remove and dispose of it safely.

It is illegal to dispose of asbestos waste in any domestic or commercial bin and doing so can incur very heavy fines. Asbestos waste should always be disposed of at a landfill licensed to accept it.

For further information about managing or disposing of household asbestos or obtaining a ‘Household Asbestos Testing (HAT) kit, contact your local council or visit the website here.

For more information on asbestos safety and National Asbestos Awareness week, visit https://www.asbestos.nsw.gov.au

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