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my personal edition > alzheimer's > news
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DGDispatch
Memantine Improves Behavioural Symptoms in Patients With Moderate to Severe Alzheimer's Disease: Presented at EFNS
By Chris Berrie
GLASGOW, UK -- September 7, 2006 -- The specific, uncompetitive N-methyl-D-aspartic acid (NMDA) receptor antagonist memantine is effective in treating and preventing behavioural symptoms associated with moderate to severe Alzheimer's disease (AD), with benefits seen for agitation/aggression and psychosis symptoms.
These findings are from a post hoc analysis of data from six multicentre, randomised, placebo-controlled, parallel-group, double-blind, 24- to 28-week studies presented here by Christina Dahl, MSc, clinical research scientist, Institute for Clinical Research in Neurology, H. Lundbeck A/S, Copenhagen, Denmark.
Memantine is the only treatment in clinical use for AD that targets the glutaminergic system, which has been implicated in the pathophysiology of a number of neurodegenerative diseases, including AD, Dr. Dahl said during her presentation here on September 3rd at the 10th Congress of the European Federation of Neurological Societies (EFNS).
The aim of this analysis was to evaluate the specific benefits of memantine 20 mg/day compared with placebo on the behavioural symptoms of patients with moderate to severe AD, defined as a Mini Memory State Examination (MMSE) score less than 20 at baseline).
The studies used for this analysis were: MEM-MD-10 (n = 403; USA; 77.5 years); MEM-MD-12 (n = 433; USA; 75.4 years); LU-99679 (n = 470; Europe; 74.0 years); MRZ90001-9605 (n = 252; USA; 76.1 years); MEM-MD-01 (n = 350; USA; 78.2 years); MEM-MD-02 (n = 403; USA; 75.7 years).
While there were minor aspects that varied between these trials, they all used the 12-item Neuropsychiatric Inventory (NPI) to measure behavioural outcomes, which allowed the researchers to pool the data for this analysis.
Christina Dahl stressed that the post hoc efficacy analysis was conducted on the full analysis set (FAS) of the intention-to-treat (ITT) populations of the pooled data from all 6 studies, as last observation carried forward (LOCF) at weeks 12 and 24. This provided the individual data for the full range of the behavioural aspects of the NPI: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviour, night-time behaviour, and appetite/eating change.
The 6 studies included a total of 2,311 patients (placebo, 1069; memantine, 1,242). Of these, 1,826 had MMSE scores < 20 (placebo, 867; memantine, 959), 1,788 of whom were include in this FAS analysis (placebo, 850; memantine, 938).
As expected, patients with moderate to severe AD showed significant improvements in total NPI scores when treated with memantine as compared with placebo at both weeks 12 and 24 (24-week LOCF, P = .008).
However, when these pooled data were analysed for the individual NPI items at weeks 12 and 24, there were significant superior effects seen for memantine over placebo as follows: week 12, delusions (P = .0066); hallucinations (P = .037); agitation/aggression (P = .001); week 24, delusions (P = .001); agitation/aggression (P = .001); irritability/lability (P = .005).
Two further subgroup analyses were performed in patients with these individual symptoms either already present at baseline or absent at baseline. At week 24, for symptoms already present, improvements with memantine were seen for delusions (P = .045), agitation/aggression (P = .028), and disinhibition (P = .048). For patients with these symptoms absent, at week 24 they were less manifest in the memantine group for agitation/ aggression (P = .001), irritability/ lability (P = .004), and night-time behaviour (P = .050).
"Memantine is actually able to treat Alzheimer's patients for their behavioural disturbances symptoms, which are a very important part of the development of the disease," Dr. Dahl stressed, with the benefits seen specifically for those aspects that are associated with rapid disease progression, increased caregiver burden, early institutionalisation, and increased direct costs of patient care.
The study was supported by H. Lundbeck A/S.
[Study title: Memantine Improves Behavioural Symptoms in Patients With Moderate to Severe Alzheimer's Disease. Abstract P1098]
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