Safety and efficacy of galantamine (Reminyl) in severe Alzheimer's disease (the SERAD study): a randomised, placebo-controlled, double-blind trial
| Autor: | Joop van Oene, Roberto Bernabei, Christoph Hock, Alfonso J. Cruz Jentoft, Eric Triau, Roger Bullock, Susanne Schwalen, Bart Van Baelen, Alistair Burns, Gerry Hammond, Anders Wimo, Minna Raivio, Lutz Frölich, Maurits Vandewoude, Elizabeth Came |
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| Přispěvatelé: | University of Zurich, Burns, A |
| Rok vydání: | 2008 |
| Předmět: |
Male
medicine.medical_specialty Activities of daily living Vital signs 610 Medicine & health Disease Neuropsychological Tests Placebo law.invention Electrocardiography Cognition Randomized controlled trial Double-Blind Method law Alzheimer Disease Internal medicine Activities of Daily Living medicine Galantamine Humans Adverse effect Nootropic Agents Aged 80 and over 11359 Institute for Regenerative Medicine (IREM) medicine.disease 2728 Neurology (clinical) Physical therapy Female Human medicine Neurology (clinical) Alzheimer's disease Psychology medicine.drug |
| Zdroj: | The lancet neurology |
| ISSN: | 1474-4422 0021-6593 |
| Popis: | Summary Background The efficacy of galantamine has been shown in patients with mild, moderate, and advanced moderate Alzheimer's disease (AD). Here we report its efficacy in patients with severe AD. Methods Between December, 2003, and March, 2007, patients aged 84 (SD 6) years with severe AD (mini-mental state examination [MMSE] score 5–12 points), in a nursing home setting were randomly assigned to receive galantamine (n=207), titrated initially to 24 mg/day, or placebo (n=200). Co-primary efficacy measures for cognitive function and ability to undertake normal daily activities were the severe impairment battery (SIB) and the seven-item minimum data set-activities of daily living (MDS-ADL), respectively. Adverse events, vital signs, laboratory parameters, and electrocardiograms were monitored. This trial is registered with ClinicalTrials.gov, number NCT00216593. Findings 168 of 207 (81%) patients in the galantamine group and 161 of 200 (81%) in the placebo group completed the study. Mean SIB scores increased (improved) by 1·9 (95% CI −0·1 to 3·9) points with galantamine and decreased (worsened) by 3·0 (−5·6 to −0·5) points with placebo (between-group least squares mean difference 4·36, 1·3 to 7·5; p=0·006). Mean MDS-ADL self-performance score worsened by 1·2 (0·6 to 1·8) points and 1·6 (0·8 to 2·3) points, respectively (between-group least squares mean difference −0·41, −1·3 to 0·5; p=0·383). Nominally significant between-group differences in favour of galantamine occurred for the SIB domains of memory (p=0·006), praxis (p=0·010), and visuospatial ability (p=0.002), and for the MDS-ADL subitem locomotion on unit (p=0·021). 183 of 207 patients (88%) who received galantamine and 177 of 200 (89%) who received placebo had adverse events, which were mostly mild to moderate. Eight patients (4%) in the galantamine group and 21 patients (11%) in the placebo group died. ECG abnormalities were similar between the two groups. Interpretation Galantamine can be started and used safely in elderly patients with severe AD. Galantamine improved cognitive function but failed to significantly improve the co-primary parameter of overall activities of daily living. Funding Janssen-Cilag EMEA. |
| Databáze: | OpenAIRE |
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