Abstract | BACKGROUND: METHODS: A placebo-controlled, double-blind, multicentre study was done in 120 patients with Lewy-body dementia from the UK, Spain, and Italy. Individuals were given up to 12 mg rivastigmine daily or placebo for 20 weeks, followed by 3 weeks rest. Assessment by means of the neuropsychiatric inventory was made at baseline, and again at weeks 12, 20, and 23. A computerised cognitive assessment system and neuropsychological tests were also used, and patients underwent close medical and laboratory safety analysis. FINDINGS: Patients taking rivastigmine were significantly less apathetic and anxious, and had fewer delusions and hallucinations while on treatment than controls. Almost twice as many patients on rivastigmine (37, 63%), than on placebo (18, 30%), showed at least a 30% improvement from baseline. In the computerised cognitive assessment system and the neuropsychological tests, patients were significantly faster and better than those on placebo, particularly on tasks with a substantial attentional component. Both predefined primary efficacy measures differed significantly between rivastigmine and placebo. After drug discontinuation differences between rivastigmine and placebo tended to disappear. Known adverse events of cholinesterase inhibitors ( nausea, vomiting, anorexia) were seen more frequently with rivastigmine than with placebo, but safety and tolerability of the drug in these mostly multimorbid patients were judged acceptable. INTERPRETATION:
Rivastigmine 6-12 mg daily produces statistically and clinically significant behavioural effects in patients with Lewy-body dementia, and seems safe and well tolerated if titrated individually.
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Authors | I McKeith, T Del Ser, P Spano, M Emre, K Wesnes, R Anand, A Cicin-Sain, R Ferrara, R Spiegel |
Journal | Lancet (London, England)
(Lancet)
Vol. 356
Issue 9247
Pg. 2031-6
(Dec 16 2000)
ISSN: 0140-6736 [Print] England |
PMID | 11145488
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Carbamates
- Cholinesterase Inhibitors
- Phenylcarbamates
- Rivastigmine
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Topics |
- Aged
- Carbamates
(therapeutic use)
- Cholinesterase Inhibitors
(therapeutic use)
- Double-Blind Method
- Female
- Humans
- Lewy Body Disease
(drug therapy)
- Male
- Middle Aged
- Phenylcarbamates
- Rivastigmine
- Treatment Outcome
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