By Patrick Holford
Reported in the media this week as a ‘breakthrough Alzheimer’s medication’ – is this really the case?
On the benefit side those in the drug company’s own trial got statistically slightly less worse after 18 months of treatment versus placebo. No-one got better. The scale of improvement was not enough to be clinically significant and “does not necessarily reflect a meaningful improvement for patients or their families” according to the British Medical Journal editorial [1]. Given that almost all drug company’s own trial perform better than independent research this is likely to be an over-estimate of benefit not an under-estimate. At best it means delaying the progress of the disease by a few months.
The worst cost is that a quarter of those on the drug got either brain swelling or bleeding.
Three participants in the trial died as a consequence. Also there was accelerated brain shrinkage compared to placebo. Due to these horrendous risks patients getting the twice monthly IV infusions will need to have brain scans to check for brain bleeding and swelling.
The drug itself will cost about £25,000 a year but, with the medical costs, it may actually cost the patients or the NHS as much as double this. That is why the NHS’s watchdog NICE have rejected it “Lecanemab provides on average four to six months’ slowing in the rate of progression from mild to moderate Alzheimer’s disease, but this is just not enough benefit to justify the additional cost to the NHS,” said Helen Knight, director of medicines evaluation at NICE. The Telegraph have stated that an inside source says other anti-amyloid drug treatments would be similarly blocked for NHS use due to bad cost benefit ratio.
—
The biggest lie reported in the papers is that ‘this is the first treatment that has been found to curb the condition’, says the Mail and ‘the first drug to slow down Alzheimer’s”, says the Telegraph.
It isn’t.
Inexpensive and safe B vitamins given to those with raised homocysteine (about half of all over age 65) have produced far greater clinical improvements to those with pre-dementia. In fact, a third had no clinical dementia rating at the end of the year – in other words were no longer diagnosable with dementia.
Similarly encouraging benefits have been shown when omega-3 fish oil supplements have been given to those with already low homocysteine (due to insufficient levels of B vitamins) – up to three times that of Lecanemab.[2] In addition, the omega-3 and B vitamin combo reported up to 73% less brain shrinkage, not more shrinkage reported with this drug. This gold-standard evidence, from studies at the University of Oxford by Professor of Pharmacology David Smith, is simply being ignored.
—
So, that’s the choice for dementia sufferers.
Safe supplements that might cost you £100 a year, reduce the rate of brain shrinkage and deliver clear clinical improvements. Or Lecanemab, that carries a small risk of death, a considerable risk of brain swelling or bleeding, has not shown improvement in a single patient, but is likely to deliver a small, clinically meaningless slowing down of worsening symptoms. NICE has not approved it for the NHS because it costs £50,000 a year and as it only slows down dementia progression by a couple of months (as reported by the BBC).
The caveat for the drug is that the risks for those with the ApoE4 gene variant – about a quarter of people are deemed too high. The caveat for the B vitamins is that those with normal homocysteine levels (below 10 mcmol/l), which is less than half those over 65, may not benefit from the B vitamin treatment. Homocysteine is a simple test any GP can do. Similarly, omega-3 fish oils may not benefit those with an omega-3 index above 8% (and highly likely to benefit those with an omega-3 index of 4% or less.)
That is why we recommend those wishing to prevent dementia test both omega-3 index and homocysteine and why we offer accurate, at-home test kits to help you reclaim your brain. When you support our charity by buying a test kit you become one of our Citizen Scientists and take part in our essential prevention-focused research and includes a free online Cognitive Function Test and the COGNITION questionnaire which calculates your future Dementia Risk Index, then advising you how to lower it.
Thank you for reading!
Food for the Brain is a non-for-profit educational and research charity that offers a free Cognitive Function Test and assesses your Dementia Risk Index to be able to advise you on how to dementia-proof your diet and lifestyle.
By completing the Cognitive Function Test you are joining our grassroots research initiative to find out what really works for preventing cognitive decline. We share our ongoing research results with you to help you make brain-friendly choices.
Please support our research by becoming a Friend of Food for the Brain.
References
[1] BMJ 2022;379:o3010 http://dx.doi.org/10.1136/bmj.o3010
[2] https://foodforthebrain.org/campaigns/alzheimers-prevention/omega-3-
and-b-vitamins/
