WFRF:(Brashear H R)
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- Winblad, BKarolinska Institutet (author)
Safety and efficacy of galantamine in subjects with mild cognitive impairment.
- Article/chapterEnglish2008
Publisher, publication year, extent ...
- 2008-03-05
- Ovid Technologies (Wolters Kluwer Health),2008
Numbers
- LIBRIS-ID:oai:gup.ub.gu.se/98802
- https://gup.ub.gu.se/publication/98802URI
- https://doi.org/10.1212/01.wnl.0000303815.69777.26DOI
- http://kipublications.ki.se/Default.aspx?queryparsed=id:117187403URI
Supplementary language notes
- Language:English
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- SwePubSwePub
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Notes
- OBJECTIVE: To assess the safety of galantamine in subjects with mild cognitive impairment (MCI), the ability of galantamine to benefit cognition and global functioning in subjects with MCI, and the ability of galantamine to delay conversion to dementia. METHODS: In two studies, 2,048 subjects, 990 in Study 1 and 1,058 in Study 2, with a Clinical Dementia Rating (CDR) = 0.5, CDR memory score > or =0.5, without dementia were randomized to double-blind galantamine (16-24 mg/day) or placebo for 24 months. Primary efficacy endpoint at month 24 was number (%) of subjects who converted from MCI to dementia (CDR > or = 1.0). RESULTS: There were no differences between galantamine and placebo in 24-month conversion rates (Study 1: 22.9% [galantamine] vs 22.6% [placebo], p = 0.146; Study 2: 25.4% [galantamine] vs 31.2% [placebo], p = 0.619). Mean CDR-sum of boxes declined less with galantamine than placebo at 12 and 24 months in Study 1 (p = 0.024 [12 months] and p = 0.028 [24 months]), but not in Study 2 (p = 0.662 [12 months] and p = 0.056 [24 months]). Digit Symbol Substitution Test scores improved with galantamine in Study 1 at 12 months and in Study 2 at 24 months (Study 1: p = 0.009 [month 12] and p = 0.079 [Month 24]; Study 2: p = 0.154 [month 12] and p = 0.020 [month 24]). The most frequently reported adverse event was nausea (galantamine, 29%; placebo, 10%). Serious AEs occurred in 19% of each group. Mortality of the cohort after retrospectively determining the status of subjects (98.3%) at 24 months was 1.4% (galantamine) and 0.3% (placebo); RR (95% CI), 1.70 (1.00, 2.90). CONCLUSIONS: Galantamine failed to significantly influence conversion to dementia. Galantamine was generally well tolerated. Whereas recorded mortality was greater in the galantamine group than in the placebo group in the original per-protocol assessment, a post hoc analysis of the cohort was consistent with no increased risk.
Subject headings and genre
- MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Psykiatri hsv//swe
- MEDICAL AND HEALTH SCIENCES Clinical Medicine Psychiatry hsv//eng
- Aged
- Aged
- 80 and over
- Alzheimer Disease
- mortality
- prevention & control
- Cognition Disorders
- drug therapy
- mortality
- psychology
- Cohort Studies
- Double-Blind Method
- Female
- Galantamine
- adverse effects
- therapeutic use
- Humans
- Male
- Middle Aged
- Retrospective Studies
Added entries (persons, corporate bodies, meetings, titles ...)
- Gauthier, S (author)
- Scinto, L (author)
- Feldman, H (author)
- Wilcock, G K (author)
- Truyen, L (author)
- Mayorga, A J (author)
- Wang, D (author)
- Brashear, H R (author)
- Nye, J S (author)
- Wallin, Anders,1950Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry(Swepub:gu)xwaand (author)
- Karolinska InstitutetInstitutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi (creator_code:org_t)
Related titles
- In:Neurology: Ovid Technologies (Wolters Kluwer Health)70:22, s. 2024-351526-632X0028-3878
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