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The Clinical Efficacy and Safety of Galantamine in the Treatment of Alzheimer's Disease

Published online by Cambridge University Press:  07 November 2014

Alan N. Dengiz  and
Paul Kershaw
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Abstract

Alzheimer's disease is a progressive, neurodegenerative condition characterized by deficits in cognition, inability to perform activities of daily living, and alterations in behavior. Galantamine hydrobromide is the newest acetylcholin esterase inhibitor (AChEI) approved in the United State for the treatment of mild-to-moderate AD. The safety and efficacy of galantamine has been demonstrated in multiple randomized, Phase III trials of > 2,600 patients with mild-to-moderate AD. Studies have found that galantamine improved or maintained performance in all domains of AD (cognition, function, behavior, and caregiver burden in the short term and slowed the decline in performance or maintained baseline performance through 12 months. The dual mechanism of action may make galantamine a reasonable treatment option for both newly diagnosed patients and patients who have not benefitted from or have poorly tolerated current therapy.

Type
Review Articles
Information
CNS Spectrums , Volume 9 , Issue 5 , May 2004 , pp. 377 - 392
Copyright
Copyright © Cambridge University Press 2004

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References

REFERENCES

1.Mayeux, R, Sano, M. Treatment of Alzheimer's disease. N Engl J Med. 1999;341:1670–1679.CrossRefGoogle ScholarPubMed
2.Evans, DA. Estimated prevalence of Alzheimer's disease in the United States. Milbank Q. 1990;68:267–289.CrossRefGoogle ScholarPubMed
3. Decision Resources, Inc. Waltham, MA; March 2000.Google Scholar
4.Maelicke, A, Albuquerque, EX. Allosteric modulation of nicotinic acetylcholine receptors as a treatment strategy for Alzheimer's disease. Eur J Pharmacol. 2000;393:165–170.CrossRefGoogle ScholarPubMed
5.Nordberg, A, Svensson, AL. Cholinesterase inhibitors in the treatment of Alzheimer's disease: a comparison of tolerability and pharmacology. Drug Saf. 1998;19:465–480.CrossRefGoogle ScholarPubMed
6.Levin, ED, Simon, BB. Nicotinic acetylcholine involvement in cognitive function in animals. Psychopharmacology (Berl). 1998;138:217–230.CrossRefGoogle ScholarPubMed
7.Levin, ED, Rezvani, AH. Development of nicotinic drug therapy for cognitive disorders. Eur J Pharmacol. 2000;393:141–146.CrossRefGoogle ScholarPubMed
8.Woodruff-Pak, DS, Vogel, RW, Wenk, GL. Galantamine: effect on nicotinic receptor binding, acetylcholinesterase inhibition, and learning. Proc Natl Acad Sci USA. 2001;98:2089–2094.CrossRefGoogle ScholarPubMed
9.Samochocki, M, Zerlin, M, Jostock, R, et al.Galantamine is an allosterically potentiating ligand of the human alpha4/beta2 nAChR. Acta Neurol Scand. 2000;176(suppl):68–73.CrossRefGoogle ScholarPubMed
10.Janssen Pharmaceutica Products LP. Reminyl (galantamine HBr tablets). Titusville, NJ. 2001.Google Scholar
11.Doody, RS, Kershaw, P. The cognitive benefits of galantamine are sustained for at least 24 months: results of a long-term extension trial in Alzheimer's disease [abstract]. Neurology. 2001;56(suppl 3):A456.Google Scholar
12.Raskind, MA, Peskind, ER, Wessel, T, Yuan, W. Galantamine in AD: a 6-month randomized, placebo-controlled trial with a 6-month extension. Neurology. 2000;54:2261–2268.CrossRefGoogle Scholar
13.MacGowan, SH, Wilcock, GK, Scott, M. Effect of gender and apolipoprotein E genotype on response to anticholinesterase therapy in Alzheimer's disease. Int J Geriatr Psychiatry. 1998;13:625–630.3.0.CO;2-2>CrossRefGoogle ScholarPubMed
14.Farlow, MR, Lahiri, DK, Poirier, J, Davignon, J, Schneider, L, Hui, SL. Treatment outcome of tacrine therapy depends on apolipoprotein genotype and gender of the subjects with Alzheimer's disease. Neurology. 1998;50:669–677.CrossRefGoogle ScholarPubMed
15.Wilcock, GK, Lilienfeld, S, Gaens, E. Efficacy and safety of galantamine in patients with mild to moderate Alzheimer's disease: multicentre randomised controlled trial. BMJ. 2000;321:1445–1449.CrossRefGoogle ScholarPubMed
16.Wilcock, G, Lilienfeld, S. Galantamine alleviates caregiver burden in Alzheimer's disease: a 6-month placebo-controlled study. Poster presented at: World Alzheimer Congress; July 9–18, 2000; Washington, DC.Google Scholar
17.Lilienfeld, S, Papadopoulos, G. Galantamine alleviates caregiver burden in Alzheimer's disease. Poster presented at: American Association for Geriatric Psychiatry; February 23–26, 2001; San Francisco, Calif.Google Scholar
18.Rockwood, K, Mintzer, J, Truyen, L, Wessel, T, Wilkinson, D, on behalf of the Galantamine International-2 Study Group. Effects of a flexible galantamine dose in Alzheimer's disease: a randomized, controlled trial. J Neurol Neurosurg Psychiatry. 2001;71:589–595.CrossRefGoogle Scholar
19.Buysse, DJ, Reynolds, CF, Monk, TH, Berman, SR, Kupfer, DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28:193–213.CrossRefGoogle ScholarPubMed
20.Tariot, PN, Solomon, PR, Morris, JC, Kershaw, P, Lilienfeld, S, Ding, C. A 5-month, randomized, placebo-controlled trial of galantamine in AD. Neurology. 2000;54:2269–2276.CrossRefGoogle ScholarPubMed
21.Kaufer, DI, Cummings, JL, Christine, D, et al.Assessing the impact of neuropsychiatric symptoms in Alzheimer's disease: the Neuropsychiatric Inventory Caregiver Distress Scale. J Am Geriatr Soc. 1998;46:210–215.CrossRefGoogle ScholarPubMed
22.Mintzer, JE, Yuan, W, Kershaw, P. Efficacy of galantamine in patients with Alzheimer's disease (AD) with previous exposure to cholinesterase inhibitors. Poster presented at: American College of Neuropsychopharmacology; December 10–14, 2000; San Juan, Puerto Rico.Google Scholar
23.Torfs, K, Feldman, H. 12-month decline in cognitive and daily function in patients with mild-to-moderate Alzheimer's disease treated with placebo in two randomized studies. Poster presented at: World Alzheimer Congress; July 9–18, 2000; Washington, DC.CrossRefGoogle Scholar
24.Feldman, H, Sauter, A, Donald, A, et al.The Disability Assessment for Dementia Scale: a 12-month study of functional ability in mild to moderate severity Alzheimer disease. Alzheimer Dis Assoc Disord. 2001;15:89–95.CrossRefGoogle Scholar
25.Rogers, SL, Doody, RS, Mohs, RC, Friedhoff, LT. Donepezil improves cognition and global function in Alzheimer disease: a 15-week, double-blind, placebo-controlled study. Donepezil Study Group. Arch Intern Med. 1998;158:1021–1031.CrossRefGoogle ScholarPubMed
26.Rogers, SL, Farlow, MR, Doody, RS, Mohs, R, Friedhoff, LT. A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer's disease. Donepezil Study Group. Neurology. 1998;50:136–145.CrossRefGoogle ScholarPubMed
27.Burns, A, Rossor, M, Hecker, J, et al.The effects of donepezil in Alzheimer's disease-results from a multinational trial. Dement Geriatr Cogn Disord. 1999;10:237–244.CrossRefGoogle ScholarPubMed
28.Rosler, M, Anand, R, Cicin-Sain, A, et al.Efficacy and safety of rivastigmine in patients with Alzheimer's disease: international randomised controlled trial. BMJ. 1999;318:633–638.CrossRefGoogle ScholarPubMed
29.Corey-Bloom, J, Anand, R, Veach, J. A randomized trial evaluating the efficacy and safety of ENA 713 (rivastigmine tartrate), a new acetylcholinesterase inhibitor, in patients with mild to moderately severe Alzheimer's disease for the ENA 713 B352 Study Group. Int J Geriatric Psychopharmacol. 1998;1:55–65.Google Scholar
30.NDTI (Diagnosis codes: 3310, 2900, 2901, 2902, 2903, 2904, 33109, 2912) July 2001.Google Scholar
31.Birks, J, Grimley, EJ, Iakovidou, V, Tsolaki, M. Rivastigmine for Alzheimet's disease. Cochrane Database Syst Rev. 2000;CD001191.Google Scholar
32.Morris, JC. Therapeutic continuity in Alzheimer's disease: switching patients to galantamine. Introduction. Clin Ther. 2001;23(suppl A):A1–A2.CrossRefGoogle ScholarPubMed
33.Morris, JC, Farlow, MR, Ferris, SH, et al.Therapeutic continuity in Alzheimer's disease: switching patients to galantamine. Panel discussion: recommendations for prescribers. Clin Ther., 2001;23(suppl A):A31–A39.CrossRefGoogle ScholarPubMed