Aricept (donepezil hydrochloride): drug treatment for Alzheimer's disease

Introduction

This information sheet is for people with Alzheimer's disease, their families and carers and for anyone else who is interested in the treatment of Alzheimer's disease. It updates an earlier version published in August 1998.

Aricept is the brand name for the drug donepezil hydrochloride. Launched in 1997, it was the first drug licensed in the UK for the treatment of mild to moderate Alzheimer's disease. Aricept treats the symptoms of Alzheimer’s disease – it is not a cure.

Aricept is one of a group of three drugs for people with Alzheimer's disease called cholinesterase inhibitors. The other two are called Exelon and Reminyl.

How does Aricept work?

Acetylcholine is a neurotransmitter, a brain chemical which carries messages between brain cells. When someone has Alzheimer's disease, it seems that - among other changes - his or her brain produces less acetylcholine. Normally there is a repeated cycle in the brain in which acetylcholine is made, transmits messages and is then broken down by a special enzyme (acetylcholinesterase).

Aricept aims to prevent the last part of this cycle so that the acetylcholine is not broken down. There is then more acetylcholine available in the brain to carry messages between the brain cells.

Who might benefit from Aricept?

Aricept is licensed only for people with mild to moderate Alzheimer's disease, and not for people with other kinds of dementia. However, people who have a less common form of dementia called Lewy body dementia may also benefit. Recent evidence suggests that Aricept may also be able to help people with severe Alzheimer's disease and people with vascular dementia.

It is important to realise that, unfortunately, Aricept will not help everyone who tries it.

Aricept is not claimed to be a cure for Alzheimer's disease. It only treats the symptoms and there is no evidence that it could halt or reverse the process of cell damage that causes Alzheimer's disease.

What effect might it have?

The effect of the drug will vary for different people. Some will not notice an effect at all. Others may find that their condition improves, or that they stay the same when they would have been expected to get gradually less able because of the progression of Alzheimer's disease.

SIGN guideline

The Scottish Intercollegiate Guidelines Network (SIGN) is an organisation which produces guidelines and recommendations on how to treat medical conditions. These recommendations are then used by health professionals, such as doctors.

In producing its guideline on the management of patients with dementia, SIGN reviewed studies which investigated the effects of Aricept. It found a lot of evidence to support the use of Aricept in people with mild to moderate Alzheimer's disease.

One study found that Aricept improved cognition (mental functions or processes, such as memory) and function (the person’s ability to carry out normal activities). However, it did not allow people to remain in their own homes for longer before going into a care home. Neither did it slow down people’s progression of disability.

Many studies have found that Aricept reduces psychotic symptoms (e.g. hallucinations) and some behavioural problems in people with mild to moderate Alzheimer's disease.

Other studies have shown benefits for people with severe Alzheimer's disease and for people with vascular dementia with a mild to moderate cognitive impairment.

SIGN recommendation

SIGN recommends that daily doses of 5 mg and above of Aricept can be used to treat cognitive decline and to manage associated symptoms in people with Alzheimer's disease.

How is Aricept taken?

Aricept is available in tablets at two strengths: 5 mg and 10 mg. It is taken once a day, in the evening. It may be taken with or without food. Patients start on 5 mg tablets. After about a month, the doctor will check to see if the person is tolerating the drug well with no side effects. If there are no side effects but the 5 mg dose doesn’t seem to be having any effect on the person’s symptoms, the doctor may recommend taking the larger 10 mg dose. The larger dose may work better.

Aricept recently became available in a form which dissolves on the tongue. This is for people who have difficulty swallowing. It is called Aricept Evess and comes in tablets of 5 mg and 10 mg.

Whichever type of Aricept is taken, it should not be crushed before consuming.

If a dose of Aricept is missed, the person should take it as close as possible to the time it would normally be taken. However, if the missing dose is not discovered until near to the time of the next dose, the missing dose should not be taken. The next dose should be taken as normal. Two doses should not be taken at once.

Are there any side effects?

Medicines can affect people in different ways causing side effects in some but not others. It is not possible to tell who will have side effects and who will not.

With Aricept, the most likely side effects are diarrhoea, nausea, vomiting, muscle cramps, difficulty in sleeping, headaches, loss of appetite and fatigue. If these or any other unusual symptoms occur, tell the doctor at once. Side effects are more common when someone begins to take Aricept, but often settle down with time. Side effects are less likely for people who start on the lower (5 mg) dose for at least a month.

Interactions with other drugs

It is important to tell the doctor about all the drugs that the person with Alzheimer's disease takes because Aricept may interact with them. This includes prescription and non-prescription drugs, vitamins, herbal remedies or dietary supplements.

Interactions with other conditions

Aricept works by increasing or maintaining levels of acetylcholine in the brain. Other drugs also increase the activity of acetylcholine and should not be taken in combination with Aricept as this may lead to increased side effects.

Some other conditions, such as stomach ulcers, lung diseases, asthma, Parkinson’s disease, urinary incontinence or some heart diseases might possibly be affected by taking Aricept. People with some of these conditions may be prescribed anticholinergic medicines. These work by decreasing levels of acetylcholine. If taken in combination with Aricept this could lead to both medicines being less effective with each drug cancelling out the effects of the other.

The doctor must be told of any previous or current diseases of the person with Alzheimer's disease and also if the person is going to have an operation which will require anaesthesia or is pregnant, trying to get pregnant or breastfeeding.

Overdose

If too much Aricept has been taken, contact a doctor or hospital straight away for advice. Take any remaining tablets and the packaging with you. NHS 24 (telephone 08454 24 24 24) may be able to give you advice when your GP practice or health centre is closed.

Stopping the drug

It is best to discuss with the doctor when to stop the drug. However, it is possible to stop immediately if the person with Alzheimer's disease or his or her carer feels this is necessary. If this is the case, the doctor should be consulted as soon as possible.

How to get Aricept

NHS prescriptions

Before 2006, people with mild and moderate Alzheimer's disease could get Aricept on NHS prescription if a doctor believed the drug could help. However, in 2006 NHS Quality Improvement Scotland (NHS QIS) decided that Aricept should only be available on NHS prescription to people with moderate Alzheimer's disease.

Moderate Alzheimer's disease is defined as a score between 10 and 20 points on a test called the Mini Mental State Examination (MMSE). MMSE is a commonly used test for people with memory problems or when a diagnosis of dementia is being considered.

The NHS QIS decision means, in theory, that people with mild Alzheimer's disease will not be eligible for Aricept until their condition gets worse and they are assessed as being in the moderate stage. In practice, the doctor will use his or her clinical judgement to determine whether or not to prescribe the drug for an individual.

The NHS QIS decision should not affect people with mild Alzheimer's disease who began taking Aricept before 2006. They can continue to take Aricept until they, their carer and/or their doctor think they should stop taking it.

Aricept can be prescribed by a specialist doctor (e.g. a psychiatrist) or sometimes by a GP. If the person with Alzheimer's disease needs to see a specialist, his or her GP will arrange this. The doctor prescribing Aricept should seek the carer’s views of the condition of the person with Alzheimer's disease as part of this process.

People taking Aricept should be reviewed every six months. The review will be done by a GP or specialist team. The review will include a number of tests, including the MMSE. Again, the carer’s views should be taken into account.

If the MMSE score stays above 10 and the results of other tests show that Aricept is having a worthwhile effect, then the person with Alzheimer's disease can continue taking Aricept. If the MMSE score is below 10, then the person may have to stop taking the drug.

Regardless of whether the person with Alzheimer's disease is suitable for drug treatment, the doctor can give information on local services that may help people to cope with the illness. People with Alzheimer's disease and their carers can also call the 24 hour Dementia Helpline free on 0808 808 3000 for information or to talk things over.

Private prescriptions

People with mild Alzheimer's disease may be able to get Aricept on a private prescription if they are unable to get it by NHS prescription. Any doctor can, in theory, write a private prescription if he or she thinks the treatment would help the person and if the doctor is willing to accept responsibility for the decision to prescribe the drug.

A private prescription can be obtained through a consultant or other specialist, a private hospital, or GP. However, hospital doctors may not be allowed by their health boards to write private prescriptions for patients after assessing them at a NHS consultation. This could mean that the person with Alzheimer's disease has to pay for a private consultation.

GPs are not allowed to charge for writing a private prescription if the patient is registered for NHS care with that GP or another GP in the same practice. However, not all GPs are willing to issue private prescriptions, and some may feel they do not have the right expertise to prescribe Aricept, as it is normally only prescribed by hospital specialists.

Private specialists will write private prescriptions if they consider the drugs would be beneficial. However, it is unlikely that they would do so without arranging to monitor the person with Alzheimer's disease for the effects of the drug. If the person with Alzheimer's disease is going to see a specialist privately, ask for a written estimate of any additional on-going costs associated with the prescription.

There are advantages to staying within the NHS system for dementia care, other than reduced cost and ongoing monitoring of your condition, such as getting access to other NHS services like community nursing, continence services and various therapies.

Take the prescription to the pharmacist or chemist, as you would with a NHS prescription.

Cost

NHS prescriptions

If the person with Alzheimer's disease is prescribed Aricept on the NHS, he or she will have to pay the normal prescription charge unless he or she is eligible for free prescriptions – ask a pharmacist for more details.

Private prescriptions

Private prescriptions are not covered by the NHS prescription charge and are not supplied free to people who do not pay prescription charges. A dispensing fee on top of the full cost of the drug will also be charged. This could be in the region of £50. It may pay to shop around if you can, as dispensing charges can vary from pharmacy to pharmacy and even between branches of the same company.

Prices for Aricept are £63.54 for 28 tablets of 5 mg and £89.06 for 28 tablets of 10 mg. This equates to £828.29 for daily doses of 5 mg for one year and £1160.96 for daily doses of 10 mg for one year

For more information on private prescriptions, see Information sheet 37 at
www.alzscot.org/pages/info/privateprescription.htm

If you or the person you care for have been refused an NHS prescription for Aricept or any of the dementia drugs, Alzheimer Scotland would like to know. Write to the Policy Director, Alzheimer Scotland, 22 Drumsheugh Gardens EH3 7RN or email alzheimer@alzscot.org