May 2022

Aducanumab (Aduhelm)

Professor Henry Brodaty provides an update on the latest, controversial anti-dementia drug

Great controversy followed. The FDA expert advisory committee almost unanimously rejected approval being given. Major hospitals in the US decided not to prescribe aducanumab. The FDA ordered an internal review of their approval process. The European Medicine Agency ruled against giving approval.

In March 2022 an independent analysis by Ross et al. published found there was no cost benefit from using this medication. On 7th April 2022, the US Centers for Medicare and Medicaid Services (CMS) confirmed that it will not approve subsidisation for medications targeting surrogate endpoints; they will only cover anti-amyloid antibody treatments in the context of clinical trials with strict conditions.

This has occurred against a background of the side effects and costs of aducanumab. The most notable side effects are brain oedema and microhaemorrhages which affected about 30% of trial participants. These generally were mild and resolved without ceasing the medication but not always.

Aducanumab is not cheap. It is given by monthly intravenous infusions for a year with the cost initially set at AUD$6000 per treatment or $AUD$72,000 for the first year. The adverse publicity and controversy led Biogen to halve the cost.

Finally, after all this activity, Biogen published on March 18, 2022 results of it two pivotal trials. In one of the studies, those on the higher dose of aducanumab did achieve significant benefits but not those on lower dose. In the other study no significant benefits were reported.

Aducanumab is one of several antibody studies underway. Both gantenerumab (Roche) and lecanemab (Biogen/Eisai) are expected to have Phase 3 data this year, with donanemab (Lilly) not far behind.

What to make of all this?

First, it is encouraging that big Pharma is investing heavily in finding a disease modifying treatment.

Secondly, despite the uncertainty of how beneficial aducanumab is, there is a strong signal of positive changes in the brain.

Questions remain about what is the best dose, to balance benefit over side effects, and which is the optimal antibody from those under development. It may be that more than one drug for Alzheimer’s will be required; combination therapy is common in many other diseases such as cancer, heart failure and Crohn’s disease.

Meanwhile, people with dementia can do a lot to maintain their quality of life. Check these articles on the Forward with Dementia website: 

• 4.2 Exercise to boost your physical health
• 4.3 Eat and drink well
• 4.4 Rest well
• 4.5 Attend to other health issues
• 4.6 Build emotional resilience
• 4.7 Be mentally active
• 4.8 Be socially active

Pet therapy

Pet therapy has grown in popularity since the 1990s and some of the known benefits for older people include:

• Improved joint movement and motor skills
• Improved independent or assisted movement
• Increased self-esteem
• Improved verbal communication and interactions with others
• Decreased depression, isolation and loneliness
• Reduced anxiety.

Types of pet therapy can range from occasional interactions between an individual or group with a pet and pet trainer (Animal Assisted Activities), through to daily reliance on a pet, such as the use of a highly trained assistance dog.

Phil’s experience with his assistance dog, Sarah

Phil Hazel was in his mid-50s when he received his dementia diagnosis (read Phil’s diagnosis story on the Forward with Dementia website).

About 12 months after the diagnosis, his psychiatrist suggested he look into an assistance or service dog. After completion of their training, service dogs are allowed anywhere except zoos, court and operating theatres. Phil’s golden Labrador, Sarah, has even stayed in hospital with him.

It cost $43,000 over two years to train Sarah. It was a very stringent training regime with exams every three months, in the lead to the public access test to become licenced. Phil has had Sarah since she was 8 weeks old. At the start, a trainer came three times a week, at a cost of $120 an hour, to train the handler and the dog. The public assess test is gruelling, but Sarah passed first time. She must complete the final exams every two years now to keep up her licence.

Labradors are mainly used as assistance dogs as they have high acceptance rates among the public. Phil has noticed some fear of dogs among groups. He adjusts if he notices this, and tries to reduce other people’s anxiety, for example, by waiting and taking another lift.

Sarah must be the happiest dog in Sydney! She gets excited when she sees her jacket, as it signals work mode! Sarah has very high skill levels, and accompanies Phil everywhere, in taxis, on walks, and on planes where she has a window seat and won’t move.

They took two flights together before Sarah graduated. First when Sarah was 9 months. She barked a couple of times as she was stressed but did not move. On their second flight, Phil took her with him when he went to the toilet and put her in the down position. But she went into business class, so he had to explain she was still in training!

When Phil first got Sarah he was not on the NDIS. He now hopes to get another pup in a couple of years and anticipates the NDIS will pay. Sarah gives Phil the confidence to do things on his own. She comforts and cuddles him when he feels uneasy, apprehensive or disorientated.

To learn more about Phil and his experience with assistance dogs, you can also watch this Dementia Alliance International webinar.

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