Journal Mobile Options
Table of Contents
Vol. 17, No. 1-2, 2004
Issue release date: December 2003
Dement Geriatr Cogn Disord 2004;17:29–34

Management of Patients with Alzheimer’s Disease plus Cerebrovascular Disease: 12-Month Treatment with Galantamine

Bullock R. · Erkinjuntti T. · Lilienfeld S. · GAL-INT-6 Study Group G.
aKingshill Research Centre, Victoria Hospital, Swindon, UK; bHelsinki University Central Hospital, Helsinki, Finland, and cJanssen Pharmaceutica, Titusville, N.J., USA

Individual Users: Register with Karger Login Information

Please create your User ID & Password

Contact Information

I have read the Karger Terms and Conditions and agree.

To view the fulltext, please log in

To view the pdf, please log in


We evaluated the long-term cognitive effects and safety of galantamine 24 mg/day in patients with Alzheimer’s disease plus cerebrovascular disease (AD + CVD or mixed dementia). Subgroup analysis was performed of patients with AD + CVD who participated in a 6-month, multicenter, randomized, double-blind, parallel-group study and a 6-month, open-label, active-treatment extension. Method: Two hundred and eighty-five patients with AD + CVD were randomized to receive either placebo (n = 97) or galantamine 24 mg/day (n = 188) for 6 months. Two hundred and thirty-eight (84%) patients continued with the open-label phase of the study (86 from the placebo group, 152 from the galantamine group) and were treated with galantamine 24 mg/day. The primary efficacy measure was cognitive performance as assessed using the eleven-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog/11). Standard safety evaluations and adverse-event monitoring were performed throughout the 12-month study period. Patients with AD + CVD treated with galantamine experienced statistically and clinically significant improvement in cognition at month 6 (mean change in ADAS-cog/11 score –1.1; p ≤ 0.05 vs. baseline) and maintained their cognitive function for the entire 12-month study (mean change in ADAS-cog/11 score +0.1). In contrast, the cognitive function deteriorated among those in the placebo group (mean change in ADAS-cog/11 at month 6 +2.0; p ≤ 0.001 vs. baseline). Patients with AD + CVD who were switched from placebo to galantamine for the open-label phase of the trial did show improvement in cognitive function; however, they never attained the same cognitive level as patients who had been treated with galantamine for the entire 12 months [mean (± SE) ADAS-cog/11 scores in the placebo/galantamine group 25.7 ± 1.32 and 24.2 ± 1.57 at months 6 and 12, respectively, and in the galantamine/galantamine group 21.5 ± 0.87 and 22.2 ± 1.06 at months 6 and 12, respectively]. The results of this subgroup analysis indicate that galantamine is effective for long-term maintenance of the cognitive function in patients with AD + CVD and is safe and well tolerated in this patient population.

Copyright / Drug Dosage

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.


  1. Jellinger KA: Alzheimer disease and cerebrovascular pathology: An update. J Neural Transm 2002;109:813–836.
  2. Snowdon DA, Greiner LH, Mortimer JA, Riley KP, Greiner PA, Markesbery WR: Brain infarction and the clinical expression of Alzheimer disease. The NUN Study. JAMA 1997;277:813–817.
  3. Pasquier F, Leys D, Scheltens P: The influence of coincidental vascular pathology on symptomatology and course of Alzheimer’s disease. J Neural Transm 1998;54(suppl):117–127.
  4. Saito H, Togashi H, Yoshioka M, Nakamura N, Minami M, Parvez H: Animal models of vascular dementia with emphasis on stroke-prone spontaneously hypertensive rats. Clin Exp Pharmacol Physiol Suppl 1995;22:S257–S259.
  5. Kimura S, Saito H, Minami M, Togashi H, Nakamura N, Nemoto M, Parvez HS: Pathogenesis of vascular dementia in stroke-prone spontaneously hypertensive rats. Toxicology 2000;153:167–178.
  6. Togashi H, Kimura S, Matsumoto M, Yoshioka M, Minami M, Saito H: Cholinergic changes in the hippocampus of stroke-prone spontaneously hypertensive rats. Stroke 1996;27:520–525.
  7. Togashi H, Matsumoto M, Yoshioka M, Hirokami M, Minami M, Saito H: Neurochemical profiles in cerebrospinal fluid of stroke-prone spontaneously hypertensive rats. Neurosci Lett 1994;166:117–120.
  8. Ferrari R, Frasoldati A, Leo G, Torri C, Zini I, Agnati LF, Zoli M: Changes in nicotinic acetylcholine receptor subunit mRNAs and nicotinic binding in spontaneously hypertensive stroke-prone rats. Neurosci Lett 1999;277:169–172.
  9. Gottfries CG, Blennow K, Karlsson I, Wallin A: The neurochemistry of vascular dementia. Dementia 1994;5:163–167.
  10. Wallin A, Alafuzoff I, Carlsson A, Eckernas SA, Gottfries CG, Karlsson I, Svennerholm L, Winblad B: Neurotransmitter deficits in a non-multi-infarct category of vascular dementia. Acta Neurol Scand 1989;79:397–406.
  11. Tohgi H, Abe T, Kimura M, Saheki M, Takahashi S: Cerebrospinal fluid acetylcholine and choline in vascular dementia of Binswanger and multiple small infarct types as compared with Alzheimer-type dementia. J Neural Transm 1996;103:1211–1220.
  12. 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.
  13. 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.
  14. 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.
  15. Wilkinson D, Murray J: Galantamine: A randomized, double-blind, dose comparison in patients with Alzheimer’s disease. Int J Geriatr Psychiatry 2001;16:852–857.
  16. Erkinjuntti T, Inzitari D, Pantoni L, Wallin A, Scheltens P, Rockwood K, Roman GC, Chui H, Desmond DW: Research criteria for subcortical vascular dementia in clinical trials. J Neural Transm 2000;59(suppl):23–30.
  17. Roman GC, Tatemichi TK, Erkinjuntti T, Cummings JL, Masdeu JC, Garcia JH, Amaducci L, Orgogozo JM, Brun A, Hofman A: Vascular dementia: Diagnostic criteria for research studies. Report of the NINDS-AIREN International Workshop. Neurology 1993;43:250–260.
  18. 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.
  19. 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.
  20. Rosen WG, Mohs RC, Davis KL: A new rating scale for Alzheimer’s disease. Am J Psychiatry 1984;141:1356–1364.
  21. Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J: The Neuropsychiatric Inventory: Comprehensive assessment of psychopathology in dementia. Neurology 1994;44:2308–2314.
  22. 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.
  23. Groves WC, Brandt J, Steinberg M, Warren A, Rosenblatt A, Baker A, Lyketsos CG: Vascular dementia and Alzheimer’s disease: Is there a difference? A comparison of symptoms by disease duration. J Neuropsychiatry Clin Neurosci 2000;12:305–315.
  24. Stern RG, Mohs RC, Davidson M, Schmeidler J, Silverman J, Kramer-Ginsberg E, Searcey T, Bierer L, Davis KL: A longitudinal study of Alzheimer’s disease: Measurement, rate, and predictors of cognitive deterioration. Am J Psychiatry 1994;151:390–396.
  25. Orgogozo JM, Rigaud AS, Stoffler A, Mobius HJ, Forette F: Efficacy and safety of memantine in patients with mild to moderate vascular dementia: A randomized, placebo-controlled trial (MMM 300). Stroke 2002;33:1834–1839.
  26. Capsoni S, Giannotta S, Cattaneo A: Nerve growth factor and galantamine ameliorate early signs of neurodegeneration in anti-nerve growth factor mice. Proc Natl Acad Sci USA 2002;99:12432–12437.

Pay-per-View Options
Direct payment This item at the regular price: USD 38.00
Payment from account With a Karger Pay-per-View account (down payment USD 150) you profit from a special rate for this and other single items.
This item at the discounted price: USD 26.50