About 750,000 people in the UK and 18 million worldwide suffer from AD. The multi-centre study, led by Professor Robert Howard at the King’s College London Institute of Psychiatry (IoP), is the first trial to demonstrate the value of continued drug intervention for those patients with moderate to severe AD who have deteriorated beyond the point where donepezil is currently recommended.
The study, published this week in the New England Journal of Medicine, looked at two drugs: donepezil and memantine. Donepezil is the most commonly prescribed of the dementia drugs and is recommended for patients at the earliest stages of Alzheimer’s disease. Doctors are currently advised to stop prescribing donezepil when the disease progresses to become moderate to severe and until now there has been no clear evidence that continuing treatment is of benefit to patients.
Over the course of the trial, which recruited individuals over a two year period with a one year follow up, patients who continued to take donepezil showed considerably less decline in cognition (memory, orientation, language function, etc) and function (retained ability to carry out simple daily tasks and self-care) than those taking a placebo drug. The benefits seen with continued treatment were clinically important and were greater than those previously seen in patients with less severe AD. Patients who started taking memantine also showed better cognitive and functional abilities, although the effect was slightly smaller, compared with those taking a placebo.
Professor Robert Howard, lead author from Institute of Psychiatry at King’s says:
“As patients progress to more severe forms of Alzheimer’s disease, clinicians are faced with a difficult decision as to whether to continue or not with dementia drugs and, until now, there has been little evidence to guide that decision. For the first time, we have robust and compelling evidence that treatment with these drugs can continue to help patients at the later, more severe stages of the disease. We observed that patients who continued taking donepezil were better able to remember, understand, communicate and perform daily tasks for at least a year longer than those who stopped taking the drugs. These improvements were noticeable to patients, their caregivers and doctors. Both donepezil and memantine will soon be off patent and available in very cheap generic preparations. These findings will greatly increase the numbers of patients in the developed and developing world whom we are able to treat.”
Professor Nick Fox,MRC Senior Clinical Fellow at the Institute of Neurology, University College London,says:
“The number of people with Alzheimer’s disease and other forms of dementia is reaching critical levels. It has never been more important to invest in research which will enable doctors to make informed decisions based on the best evidence possible when deciding what treatments to give patients. The MRC has an ongoing commitment to the development of effective, safe treatments that will improve the quality of life for people with Alzheimer’s disease and their care givers.”
Professor Clive Ballard, Director of Research at Alzheimer’s Society, says:
“Thanks to the Alzheimer’s drug donepezil, tens of thousands of people in the early to moderate stages of the condition are able to recognise their family for longer, play with their grandchildren and make vital plans for the future. This major new trial now shows that there could also be significant benefits from continuing the treatment into the later stages too. There are 750,000 people with dementia in the UK yet currently prescription levels of Alzheimer’s drugs are still low. If this is to change we have to improve the shocking diagnosis rates and ensure everyone is given the opportunity to try treatments.”
The study was sponsored by King’s College London and funded by the UK Medical Research Council (MRC) and Alzheimer’s Society. Pfizer-Eisa and Lundbeck donated supplies of drugs but had no involvement in the study design, conduct, analyses or reporting.
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Notes to editors
1. Howard et al ‘Donepezil and Memantine for Moderate-to-Severe Alzheimer’s Disease’ is published in New England Journal of Medicine.
Researchers followed 295 patients living in London and 14 other UK centres to investigate different drug regimens on patients who had been previously treated with donepezil. The trial recruited patients for 25 months. The follow up was 52 weeks for the primary outcomes.
2. The trial was split into four different arms:
(i) continue donepezil;
(ii) stop donepezil and receive a placebo;
(iii) stop donepezil and receive memantine;
(iv) take both donepezil and memantine in combination.
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King’s College London is one of the top 30 universities in the world (2011/12 QS international world rankings), and was The Sunday Times ‘University of the Year 2010/11’, and the fourth oldest in England. A research-led university based in the heart of London, King’s has nearly 23,500 students (of whom more than 9,000 are graduate students) from nearly 140 countries, and some 6,000 employees. King’s is in the second phase of a £1 billion redevelopment programme which is transforming its estate.
King’s has an outstanding reputation for providing world-class teaching and cutting-edge research. In the 2008 Research Assessment Exercise for British universities, 23 departments were ranked in the top quartile of British universities; over half of our academic staff work in departments that are in the top 10 per cent in the UK in their field and can thus be classed as world leading. The College is in the top seven UK universities for research earnings and has an overall annual income of nearly £525 million (year ending 31 July 2011).
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About Alzheimer’s Society
- One in three people over 65 will die with dementia
- Alzheimer’s Society research shows that 750,000 people in the UK have a form of dementia, more than half have Alzheimer’s disease. In less than ten years a million people will be living with dementia. This will soar to 1.7 million people by 2051
- Alzheimer’s Society champions the rights of people living with dementia and the millions of people who care for them
- Alzheimer’s Society works in England, Wales and Northern Ireland
- Alzheimer’s Society supports people to live well with dementia today and funds research to find a cure for tomorrow. We rely on voluntary donations to continue our vital work. You can donate now by calling 0845 306 0898 or visiting alzheimers.org.uk
- Alzheimer’s Society provides a National Dementia Helpline, the number is 0845 300 0336 or visit alzheimers.org.uk