Alzheimer's disease - donepezil, galantamine, rivastigmine (review) and memantine

Summary

Text explaining the new TA111 recommendations

Following the outcome of a judicial review in August 2007, NICE has amended and reissued this guidance.  The amended guidance clarifies the steps healthcare professionals should take when assessing whether Alzheimer's disease is of moderate severity and highlights that clinicians should be mindful of the need to secure equality of access to treatment.

The amendments include new text that specifically addresses assessments, using the Mini Mental State Examination (MMSE) for patients:

• where the MMSE is not, or is not by itself, a clinically appropriate tool for assessing the severity of that patient's dementia because of the patient's learning or other disabilities (for example, sensory impairments) or linguistic or other communication difficulties

or

• where it is not possible to apply the MMSE in a language in which the patient is sufficiently fluent for it to be an appropriate tool for assessing the severity of dementia, or there are similarly exceptional reasons why use of the MMSE, or use of the MMSE by itself, would be an inappropriate tool for assessing the severity of dementia in that individual patient's case.

Summary of guidance

Donepezil, galantamine and rivastigmine are recommended as options for the treatment of moderate Alzheimer's disease only. Memantine is not recommended as an option for people with moderately severe to severe Alzheimer's disease unless it is being used as part of a clinical trial (research).

When using the Mini Mental State Examination (MMSE) to assess the severity of Alzheimer's disease, healthcare professionals should make sure that people from different ethnic or cultural backgrounds and people with disabilities have equal access to treatment.

In some cases, healthcare professionals should not rely on the MMSE test - or not rely on it alone - to assess whether someone has moderate Alzheimer's disease. This may be the case when assessing people who:

• have learning disabilities or other disabilities such as deafness or blindness, or
• have difficulty speaking (for example, after a stroke) or other difficulties with communicating, or
• are not fluent enough in a language in which the MMSE test can be given

if this means that the MMSE test will not fairly reflect the severity of the disease.

For these people, healthcare professionals should use a different method to judge whether the person has moderate Alzheimer's disease when deciding about starting or stopping treatment.

Update

NICE has lodged an application for permission to appeal with the House of Lords against the Court of Appeal's ruling to release the executable version of the economic model in the Alzheimer's appraisal. The decisions NICE makes are amongst the most difficult in public life and we work hard to ensure that the way we make decisions is transparent and fair. We very much hope that the House of Lords will hear this appeal but we are unable to comment any further at this stage.

Documents

For healthcare professionals

• TA111 Alzheimer's disease - donepezil, galantamine, rivastigmine (review) and memantine: guidance (amended September 2007) (MS Word format)
• TA111 Alzheimer's disease - donepezil, galantamine, rivastigmine (review) and memantine: guidance (amended September 2007)
• TA111 Alzheimer's disease - donepezil, galantamine, rivastigmine (review) and memantine: quick reference guide (amended September 2007)
• TA111 Alzheimer's disease - donepezil, galantamine, rivastigmine (review) and memantine: quick reference guide
• TA111 Alzheimer's disease - donepezil, galantamine, rivastigmine (review) and memantine: guidance (MS Word format)
• TA111 Alzheimer's disease - donepezil, galantamine, rivastigmine (review) and memantine: guidance

For patients, carers and the public

• TA111 Donepezil, galantamine, rivastigmine a memantine ar gyfer clefyd Alzheimer: Deall canllawiau NICE: (MS Word format)
• TA111 Alzheimer's disease - donepezil, galantamine, rivastigmine (review) and memantine: Understanding NICE guidance (amended September 2007)
• TA111 Alzheimer's disease - donepezil, galantamine, rivastigmine (review) and memantine: Understanding NICE guidance (MS Word format)
• TA111 Alzheimer's disease - donepezil, galantamine, rivastigmine (review) and memantine: Understanding NICE guidance

Background information

• 2007/049 NICE complies with judge's ruling on judicial review
• Background briefing: outcome of judicial review (amended September 2007)
• Background briefing: outcome of judicial review
• 2007/042 NICE responds to judicial review outcome

Implementing this guidance

The slide set below has been produced to support the implementation of the NICE guidance on Dementia.

It appears as a link on this page as it also contains information about the technology appraisal TA111 Alzheimer's disease - donepezil, galantamine, rivastigmine (review) and memantine.

Any further information NICE has produced to help the NHS implement this guideline locally is linked to below:

• Memory assessment service commissioning guide
• Alzheimer's disease - donepezil, galantamine, rivastigmine (review) and memantine: Audit criteria
• Alzheimer's disease - donepezil, galantamine, rivastigmine (review) and memantine: costing report and template
• CG42 Dementia: Presenter slides