The clinical trial protocol of the Metrifonate in Alzheimer's Trial(MALT)
I.G. McKeith
Bok Engelsk 1998
| Utgitt | 1998
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| Omfang | Side 2- 7
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| Opplysninger | The promising results of early trials in Alzheimer's disease with theacetylcholinesterase inhibitor metrifonate prompted initiation of theMetrifonate in ALzheimer's Trial (MALT). MALT is an international,randomized, double-blind, placebo-controlled, parallel-group studywhich was designed to determine, over a 26-week period, the efficacy,tolerability and safety of two doses of metrifonate in patients withprobable Alzheimer's disease. A total of 605 patients were randomizedto receive either a daily dose of oral metrifonate 40/50 mg (n = 200,by body weight <65 kg/greater than or equal to 65 kg) or metrifonate60/80 mg (n = 197, by body weight <65 kg/greater than or equal to 65kg). Patients were assessed in the key symptom domains of Alzheimer'sdisease, i.e. Cognition, behavioural and psychiatric disturbances,activities of daily living and global function. In summary,administration of metrifonate for 26 weeks to the intent-to-treatpopulation significantly benefited cognitive performance, globalfunction and certain aspects of behaviour and functional abilitycompared with placebo. These efficacy results were associated withhigh levels of acetylcholinesterase inhibition and a good safety andtolerability profile. The protocol of MALT is discussed here. Fullresults of the study will be available in a separate publication.
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| Emner |
