Which indication is Axura® approved for?
Treatment of patients with moderate to severe Alzheimer's disease.
Many tests for Alzheimer’s disease are complicated – are there any simple means of getting the diagnosis?
There are a few rather simple tests such as the clock drawing test and the Mini-Mental State Examination (MMSE). These tests can be done quickly and put little strain on the patient. They are ideal guide for deciding if a reported or suspected cognitive dysfunction needs further diagnostic procedures or not. In case of a positive result, the diagnosis should be verified by a specific test for Alzheimer’s disease according to Diagnostic Manual of Mental Disorders, fourth edition (DSM-IV) or the definitions contained in the National Institute of Neurologic, Communicative Disorders and Stroke - AD and Related Disorders Associations (NINCDS-ADRDA).
I find it difficult to distinguish between mild, moderate and severe dementia – are there any simple tests?
Once Alzheimer’s disease has been diagnosed the progression of the disease can be followed up by a memory test. The best-known and probably most widely used screening test for memory dysfunction is the Mini-Mental State Examination (MMSE). It consists of 30 questions and instructions for actions which the patient should perform, and allows a fast and very accurate diagnosis of cognitive impairments that are relevant in everyday life. Limitations of the MMSE include the floor effect, i.e. it is less useful in the low range, which is the score you find in advanced dementia. There is also a ceiling effect, i.e. well-educated patients may get 30 points even though you feel clinically that the patient meets the criteria for dementia. The severity of dementia can be determined fairly easily with the Mini-Mental State Examination (MMSE). Scores range from 25 – 30 for healthy subjects, 21 – 24 for mild, 14 – 20 for moderate, and less than 13 in severe Alzheimer’s disease.
Do I have to exclude vascular dementia before prescribing Axura®?
Vascular dementia is no contraindication for memantine treatment. Axura® is only approved for patients with moderate to severe Alzheimer's disease. However, there are published studies that have shown a positive effect of Axura® on the cognitive performance of patients with vascular dementia4. Thus a vascular dementia component does not necessarily have to be excluded.
Does Axura® work in vascular dementia? Are there any data on the efficacy of memantine in vascular dementia?
There are currently two published studies in patients with vascular dementia4. Both showed a significant advantage of memantine on cognitive performance. Further studies, which may in time lead to an extension of the indication, will have to be conducted.
Why is Axura® not approved for patients with mild Alzheimer's disease – does it not work in this patient group?
The clinical development program was set up to start with studies in severely demented patients. Clinical trials in mild to moderate Alzheimer’s disease are ongoing and certainly a line extension for this indication is planned. As Axura® is effective in moderate to severe Alzheimer’s disease5, a beneficial effect in the early stages of the disease is expected.
If Axura® can inhibit disease progression, shouldn't it be used as early as possible in the course of the disease?
Currently, there are animal tests and in vitro experiments which indicate that Axura® has a neuroprotective effect. The results of these studies suggest that the compound may also inhibit the progression of disease. If this hypothesis can be confirmed in clinical trials, it would certainly be advisable to use memantine as early as possible.
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