Galantamine in AD: A 6-month randomized, placebo-controlled trial with a 6-month extension

Neurology

Volumn 54, Issue 12, 2000, Pages 2261-2268

  Raskind, Murray A ^a,c   Peskind, E R ^a   Wessel, T ^b   Yuan, W ^b  

^a UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^b JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^c Veterans Affairs Puget Sound   (United States)

Author keywords

Acetylcholinesterase inhibition; AD; Allosteric modulation; Galantamine; Long term efficacy; Nicotinic receptors; Randomized controlled trial; Tolerability

Indexed keywords

CHOLINESTERASE INHIBITOR; GALANTAMINE; NICOTINIC RECEPTOR; PLACEBO;

AGED; ALZHEIMER DISEASE; ARTICLE; CLINICAL TRIAL; COGNITION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG TOLERABILITY; FEMALE; FUNCTIONAL ASSESSMENT; GASTROINTESTINAL SYMPTOM; GENOTYPE; HUMAN; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

EID: 0034720816     PISSN: 00283878     EISSN: None     Source Type: Journal    
DOI: 10.1212/WNL.54.12.2261     Document Type: Article

References (40)

1. Giacobini E. The cholinergic system in Alzheimer's disease. Prog Brain Res 1990;84:321-332.
2. Davies P, Maloney AJF. Selective loss of central cholinergic neurons in Alzheimer's disease. Lancet 1976;ii:1403.
3. Whitehouse PJ, Price DL, Struble RG, Clark AW, Coyle JT, Delon MR. Alzheimer's disease and senile dementia: loss of neurons in the basal forebrain. Science 1982;215:1237-1239.
4. Coyle JT, Price DL, DeLong MR. Alzheimer's disease: a disorder of cortical cholinergic innervation. Science 1983;219:1184-1190.
5. Schneider LS. New therapeutic approaches to Alzheimer's disease. J Clin Psychiatry 1996;57(suppl 14):30-36.
6. Nordberg A, Svensson A-L. Cholinesterase inhibitors in the treatment of Alzheimer's disease: a comparison of tolerability and pharmacology. Drug Saf 1998;19:465-480.
7. Pryse-Phillips W. Do we have drugs for dementia? Arch Neurol 1999;56:735-737.
8. Bores GM, Huger FP, Petko W, et al. Pharmacological evaluation of novel Alzheimer's disease therapeutics: acetylcholinesterase inhibitors related to galanthamine. J Pharmacol Exp Ther 1996;277:728-738.
9. Thomsen T, Kewitz H. Selective inhibition of human acetylcholinesterase by galanthamine in vitro and in vivo. Life Sci 1990;46:1553-1558.
10. Schrattenholz A, Pereira EFR, Roth U, Weber K-H, Albuquerque EX, Maelicke A. Agonist responses of neuronal nicotinic acetylcholine receptors are potentiated by a novel class of allosterically acting ligands. Mol Pharmacol 1996;49:1-6.
11. Albuquerque EX, Alkondon M, Pereira EFR, et al. Properties of neuronal nicotinic acetylcholine receptors: pharmacological characterization and modulation of synaptic function. J Pharmacol Exp Ther 1997;280:1117-1136.
12. Levin ED, Simon BB. Nicotinic acetylcholine involvement in cognitive function in animals. Psychopharmacology (Berl) 1998;138:217-230.
13. Lawrence AD, Sahakian BJ. The cognitive psychopharmacology of Alzheimer's disease: focus on cholinergic systems. Neurochem Res 1998;23:787-794.
14. Newhouse PA, Potter A, Levin ED. Nicotinic system involvement in Alzheimer's and Parkinson's diseases: implications for therapeutics. Drugs Aging 1997;11:206-228.
15. McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's disease. Neurology 1984;34:939-944.
16. Folstein MF, Folstein SE, McHugh PR. "Mini-mental state": a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975;12:189-198.
17. Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry 1984;141:1356-1364.
18. Schneider LS, Olin JT, Doody RS, et al, and the Alzheimer's Disease Cooperative Study. Validity and reliability of the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change. Alzheimer Dis Assoc Disord 1997;11(suppl 2):S22-S32.
19. Mohs RC, Knopman D, Petersen RC, et al. Development of cognitive instruments for use in clinical trials of antidementia drugs: additions to the Alzheimer's Disease Assessment Scale that broadens its scope. The Alzheimer's Disease Cooperative Study. Alzheimer Disease Assoc Disord 1997;11(suppl 2):S13-S21.
20. Food and Drug Administration. Peripheral and Central Nervous System Drugs Advisory Committee Meeting, July 7, 1989. Rockville, MD: Department of Health and Human Services, Public Heath Service, Food and Drug Administration, 1989:227.
21. Gelinas I, Gauthier L, McIntyre M, Gauthier S. Development of a functional measure for persons with Alzheimer's disease: the disability assessment for dementia. Am J Occup Ther 1999;53:471-481.
22. Wenham PR, Price WH, Blundell G. Apolipoprotein E genotyping by one-stage PCR. Lancet 1991;337:1158-1159.
23. Van Elteren PH. On the combination of independent two-sample tests of Wilcoxon. Bull Inst Intern Stat 1960;37:351-361.
24. Knapp MJ, Knopman DS, Solomon PR, Pendlebury WW, Davis CS, Gracon SI, and the Tacrine Study Group. A 30-week randomized controlled trial of high-dose tacrine in patients with Alzheimer's disease. JAMA 1994;271:985-991.
25. Rogers SL, Farlow MR, Doody RS, Mohs R, Friedhoff LT, and the Donepezil Study Group. A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer's disease. Neurology 1998;50:136-145.
26. Rösler M, Anand R, Cicin-Sain A, et al, on behalf of the B303 Exelon Study Group. Efficacy and safety of rivastigmine in patients with Alzheimer's disease: international randomised controlled trial. BMJ 1999;318:633-638.
27. Morris JC, Cyrus PA, Orazem J, et al. Metrifonate benefits cognitive, behavioral, and global function in patients with Alzheimer's disease. Neurology 1998;50:1222-1230.
28. Antuono PG. Effectiveness and safety of velnacrine for the treatment of Alzheimer's disease: a double-blind, placebo-controlled study. Mentane Study Group. Arch Intern Med 1995;155:1766-1772.
29. Burns A, Rossor M, Hecker J, et al, and the International Donepezil Study Group. The effects of donepezil in Alzheimer's Disease: results from a multinational trial. Dement Geriatr Cogn Disord 1999;10:237-244.
30. Corey-Bloom J, Anand R, Veach J for the ENA 713 B352 Study Group. 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. Int J Geriatr Psychopharmacol 1998;1:55-65.
31. Farlow MR, Lahiri DK, Poirer J, Davignon J, Hui S. Treatment outcome of tacrine therapy depends on apolipoprotein genotype and gender of the subjects with Alzheimer's disease. Neurology 1998;50:669-677.
32. MacGowan SH, Wilcock G, 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.
33. Farlow MR, Cyrus PA, Nadel A, Lahiri DK, Brashear A, Gulanski B. Metrifonate treatment of AD: influence of APOE genotype. Neurology 1999;53:2010-2016.
34. Rogers SL, Friedhoff LT. Long-term efficacy and safety of donepezil in the treatment of Alzheimer's disease: an interim analysis of the results of a US multicentre open label extension study. Eur Neuropsychopharmacol 1998;8:67-75.
35. Imbimbo BP, Verdelli G, Martelli P, Marchesini D, and the Eptastigmine Study Group. Two-year treatment of Alzheimer's disease with eptastigmine. Dement Geriatr Cogn Disord 1999;10:139-147.
36. Stern RG, Mohs RC, Davidson M, et al. A longitudinal study of Alzheimer's disease: measurement, rate and predictors of cognitive deterioration. Am J Psychiatry 1994;151:390-396.
37. Mohs RC, Ferris SH. Measuring response to treatment in Alzheimer's disease: what constitutes meaningful change? Int J Geriatr Psychopharmacol 1998;1(suppl 1):S7-S14.
38. The Canadian Study of Health and Aging. Patterns of caring for people with dementia in Canada. Can J Aging 1994;13: 470-487.
39. Farlow MR, Evans RM. Pharmacologic treatment of cognition in Alzheimer's dementia. Neurology 1998;51(suppl 1):S36-S44.
40. Tariot PN, Solomon PR, Morris JC, et al. A 5-month, randomized, placebo-controlled trial of galantamine in AD. Neurology 2000;54:2269-2276.