Alzheimers
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July 09 2010
Global breakthrough in treatment of dementia ‘within reach’
A Glasgow-based medical research company is leading a worldwide sleep study which could radically reduce the symptoms associated with dementia.
The groundbreaking trial, conducted by CPS Research, is the first of its kind to investigate the use of sleep hormone melatonin as an add on treatment for dementia. The study is already showing remarkable initial results in volunteers from Scotland.
Melatonin is the natural hormone produced at night to prepare the body for sleep and produced throughout the night to maintain sleep. Older people with dementia often experience difficulties sleeping. Disturbance during the night is frequently the final problem that drives relatives to seek admission to care – a distressing outcome for the patient and their relatives and friends.
Older people produce less melatonin, and researchers with CPS Research observed that patients with dementia in particular produce very little melatonin. Drug company Neurim Pharmaceuticals, led by Nava Zisapel, the world’s leading expert on melatonin, has developed Circadin® a pill, to be taken at bedtime, which could potentially alleviate the symptoms of sleeplessness and anxiety frequently associated with Alzheimer’s patients. Circadin® mimics the same slow and controlled release of melatonin as occurs in the body of a healthy young adult.
Scotland is the first country to take part in the worldwide trial. Before the study is rolled out internationally, CPS Research is seeking to engage with 100 patients in Scotland to take part in the study over a period of nine months.
Dr Gordon Crawford of CPS Research said, “Dementia can be a shattering condition for patients, their families and friends. CPS Research is extremely encouraged by the positive early results in our world wide melatonin study.
“Melatonin does not currently exist as a treatment for dementia but is registered in Europe and the UK for use in older patients . It has proven remarkably safe and virtually free from side effects.
“With the help of volunteers from Scotland and worldwide we aim to establish that Melatonin helps combat sleeplessness in dementia patients; that a restful and undisturbed sleep helps patients with dementia function better daily and that taking melatonin makes the symptoms of dementia less severe.”
Case Study
Esther, a patient with Alzheimer’s is currently taking part in the CPS Research 7-month trial of melatonin in Alzheimer’s disease. She lives with her husband Mike, who has become her full-time carer. (All names have been changed).
Mike (XXX age) said: “I first started to notice something was amiss two years ago when Esther seemed to lose her sense of direction. I took her to a new Tesco store and she just didn’t know where she was. At first I thought it might be the layout of the store that was confusing her. But then I realised it was more than that. We were only visiting a new supermarket but Esther was completely lost.
“After that incident she never completely regained her capabilities. She became more and more forgetful, disorientated and confused. I became her full-time carer, as well as cook and cleaner.
“As the Alzheimer’s progressed she found sleeping almost impossible. She was getting at most an hour, maybe two at night. I would wake up and hear her wandering about. I would try to persuade her to go back to bed but couldn’t go back to sleep myself – I was so worried she would fall and hurt herself.
“We were awake all night and worried all day. With neither of us able to sleep our energy levels were very low, and the lack of sleep seemed to just make the confusion worse. I was very tired but so frightened she might wander off I would try and stay awake to watch her all day. If we were out walking I would tell her “hold tightly to my hand and don’t let go” - I was so frightened she might wander off and I would lose her.
“The doctor diagnosed a popular Alzheimer’s drug but it didn’t seem to improve her symptoms much and certainly not her sleep. So we made the decision to get involved in the Melatonin trials because we didn’t feel we had much to lose.
“Within a week I started to notice an incredible change in Esther’s sleep patterns. Now she takes the medicine at 8pm, is in bed by 11 and sleeps solidly for six or seven hours every night. If I wake up at dawn and check on her she’s in a very noticeable deep sleep.
“I think a full night’s sleep is having a tremendous effect on her memory function. When we visit the local health centre and they ask her to spell words backwards she’s faster than me! They say her memory function is improving. I still keep a close eye on her but now she can navigate herself much better, even making visits to a neighbour three doors down by herself. I would describe the improvement as nothing short of phenomenal.”
Esther (79), a former nurse said: “I first began to notice something was wrong three years ago. My ability to forward plan started to deteriorate. I’d leave the house to buy something and come back without it. If I’d decided in the morning there was something I was going to do that day, by the afternoon I’d forgotten what it was. As a retired nurse I had my suspicions this might not be a passing phase. But I didn’t see a doctor. I just tried to put it to the back of my mind. But then there would be times when I’d forget I’d ever been a nurse! My memory was starting to fail me and as the problem became worse I became more and more anxious. At the same time my ability to sleep deteriorated dramatically.
“But since I joined the study I’ve noticed a big difference. I’m much more settled and less agitated. The big difference is the amount I sleep – about seven hours every night – and if there are times I can’t sleep at least now I can lie in bed and relax. I feel much less tired and confused. I can visit neighbours by myself and follow conversations and still have my say and some independence which is so important to me. We’ve been told Alzheimer’s is a progressive condition and we have to take each day as it comes. But I am so glad to see a real improvement. For Mike’s sake as well as my own.”
To take part in the trial of melatonin in Alzheimer’s disease contact a nurse at CPS Research researcher:
(Freephone) 0800 731 2647
MORE ABOUT ALZHEIMERS
Alzheimer's disease is a distressing condition characterised by steady deterioration in both memory and mental function. Many patients, much against the wishes of both the patient and their relatives, spend their last months or even years in a nursing home. Why do they need admitted? After long periods of relatives or carers coping successfully, it is often the night-time disturbance caused by patients sleeping on and off during the day and then up half the night which finally leads to admission.
Current treatments with sleeping pills, antidepressants and modern antipsychotic drugs are far from satisfactory and may actually make the basic condition worse. The reasons for sleep disturbance associated with Alzheimer's disease are many, but one major one being increasingly recognized is that patients with Alzheimer's disease fail to produce melatonin, the natural hormone which prepares our body for sleep at night. Melatonin is already widely used for older patients with sleep problems, and it is possible that Alzheimer’s patients may particularly benefit.
CPS Research is conducting a study using a slow-release melatonin medicine (which is already marketed) and are looking for Alzheimer’s disease patients who are having trouble sleeping. We will arrange for a full assessment of their general health and sleeping patterns. Suitable patients will be offered access to a study assessing the treatment of sleep disturbance in Alzheimer's disease with slow-release melatonin for up to six months.
For more information please contact one of our research nurses on 0800 085 6029 or send an email to sleep@cpsresearch.co.uk
