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Neurology. 2008 May 27;70(22):2024-35. doi: 10.1212/01.wnl.0000303815.69777.26. Epub 2008 Mar 5.

Safety and efficacy of galantamine in subjects with mild cognitive impairment.

Collaborators (206)

Dal-Bianco P, Demschik G, Marksteiner J, Schmidt R, Borrie M, Bouchard R, Davidson W, Feldman H, Gauthier S, Guzman D, Hogan D, Muresan L, MacKnight C, McCracken P, Robillard A, Alhainen K, Erkinjuntti T, Pirttilä T, Albarède JL, Belliard S, Boulliat J, Dartigues JF, Froelich L, Henn F, Heuser I, Huell M, Kurz A, Maurer K, Riepe M, Steinwachs KC, Boelaarts L, Kalisvaart CJ, Dautzenberg PL, Sanders E, Scheltens P, Verhey F, Barcikowska M, Bilikiewicz A, Druzdz A, Kloszewska I, Kozubski W, Ochudlo S, Piechowski A, Pruchnik-Wolińska D, Andreasen N, Eriksson S, Marcusson J, Minthon L, Passant U, Wallin A, Winblad B, Barker A, Bullock R, Inglis F, Martin S, Wilcock G, Wilkinson D, Arias BJ, Baumel B, Chippendal T, De La Gandara J, DeKosky S, Doria J, Eastman J, Eisner L, Ellis J, Ferris S, Forchetti CM, Lossad M, Goldstein J, Grubbs J, Holub R, Kaye J, Levin K, Mintzer J, Moldauer L, Munoz DR, Richter R, Royall D, Sadowsky C, Salloway S, Scharre D, Schneider A, Scinto L, Seltzer B, Stoukides J, Thein S, Tilker H, Tune L, VanDyck C, Weiner M, Wendt J, Wilks K, Winston J, Allegri RF, Dominguez RO, Famulari AL, Garau ML, Kremer JL, Petracca GM, Reich EG, Taragano FE, Ames D, Taubman K, Boundy K, Brodaty H, Chiu E, Clarnette R, Hecker J, Kurrle S, Merory J, Bourgeois P, Cras P, De Deyn P, Michielsens B, Salmon E, Uytdenhoef P, Van De Looverbosch D, Van Orshoven M, Vandengerghe R, Willems C, Arts R, Black S, Borrie M, Cohen S, DeCoteau E, Garcia A, Jarrett P, Kertesz A, Marotta G, Molloy W, Nasreddine Z, Vaitekunas, Holmerova I, Jirak R, Konrad J, Kumpel Q, Malkova M, Roban J, Rytirova M, Stankova Z, Zizka V, Aharon-Peretz J, Kidron D, Korczyn A, Ravona-Springer R, Treves T, Gilchrist N, Aguilar M, Boada M, Fernández M, Fernández O, Frank A, Ribera Casado J, Adler L, Aronson SM, Bartel DR, Baumel B, Cohen SR, Concha M, Doraiswamy PM, Doria JJ, Edwards K, Eisen S, Ellis J, Farmer MV, Feldman R, Forchetti CM, Furman S, Gerard G, Gordon ML, Green PM, Halbert M, Harris J, Hassman HA, Hoekstra JA, Jacome A, Kassicieh VD, Katz IR, Kennedy GJ, Kobetz SA, Kosieradzki P, Levy M, Lindahl LS, Loigman M, Lossada MJ, Luthra V, McEntee WJ, Miller A, Moreines R, Porsteinsson A, Rajani R, Richardson B, Roffman M, Rosenthal MH, Sadowsky CH, Safirstein B, Salloway S, Schneider LS, Segal S, Siegal AP, Taylor Lv, Thein S, Tilker HA, Umbert M, Wilks K.

Erratum in

  • Neurology. 2010 Oct 19;75(16):1485.

Abstract

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.

PMID:
18322263
[PubMed - indexed for MEDLINE]
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