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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 (Namenda) also showed better cognitive and functional abilities, although the effect was slightly smaller, compared with those taking a placebo.
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Research funded by the Medical Research Council (MRC) and the Alzheimer’s Society has found that the dementia drug donepezil, already widely used to treat mild to moderate Alzheimer’s disease (AD), also helps in moderate to severe patients and extending treatment to this group could help treat twice as many sufferers worldwide. Encouragingly, the drug has greater positive benefits for patients more severely affected than for those in the earlier stages of dementia.
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 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.
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.
About King's College London
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.
Sources: Donepezil and Memantine for Moderate-to-Severe Alzheimer's Disease
U.K. Medical Research Council
Drugs tested on advanced Alzheimer's
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