Drugs & Aging

, Volume 20, Issue 10, pp 777–789 | Cite as

A Long-Term Comparison of Galantamine and Donepezil in the Treatment of Alzheimer’s Disease

  • Gordon Wilcock
  • Ian Howe
  • Hilary Coles
  • Sean Lilienfeld
  • Luc Truyen
  • Young Zhu
  • Roger Bullock
  • Paul KershawEmail author
Original Research Article



To compare the long-term efficacy and safety of galantamine 24 mg/day and donepezil 10 mg/day in patients with Alzheimer’s disease.

Patients and Study Design

This was a rater-blinded, randomised, parallel-group multicentre study (18 outpatient clinics) in the UK. 182 patients (69 male, 113 female) with Alzheimer’s disease were randomised to galantamine (n = 94) or donepezil (n = 88) for 52 weeks.

Main outcome measures

The effects of galantamine and donepezil on function using the Bristol Activities of Daily Living Scale (BrADL); cognition using the Mini-Mental State Examination (MMSE) and Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog/11); behaviour using the Neuropsychiatric Inventory (NPI); caregiver burden using the Screen for Caregiver Burden; and safety were assessed.


BrADL total scores showed no significant difference between treatment groups in mean change from baseline to week 52. In the total population, in terms of cognition, galantamine patients’ scores on the MMSE at week 52 did not differ significantly from baseline (−0.52 ± 0.39, p < 0.5 vs baseline), whereas donepezil patients’ scores deteriorated significantly from baseline (−1.58 ± 0.42, p < 0.0005 vs baseline). The between-group difference in MMSE change, which showed a trend for superiority of galantamine, did not reach statistical significance (p < 0.1). In the ADAS-cog/11 analysis, between-group differences for the total population were not significant, whereas galantamine-treated patients with MMSE scores of 12–18 demonstrated an increase (worsening) in the ADAS-cog/11 score of 1.61 ± 0.80 versus baseline, compared with an increase of 4.08 ± 0.84 for patients treated with donepezil, with a significant between-group difference in favour of galantamine (p ≤ 0.05). More caregivers of patients receiving galantamine reported reductions in burden compared with donepezil. Changes from baseline in NPI were similar for both treatments.

Both treatments were well tolerated; most adverse events were transient and of mild-to-moderate intensity, and were consistent with the findings of previous clinical trials.


Significant advantages were found in the treatment response to galantamine (versus donepezil) on cognition as measured by response rates on the MMSE and ADAS-cog/11.


MMSE Score Galantamine Caregiver Burden Neuronal Nicotinic Receptor Baseline MMSE Score 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



The principal investigators of this study were: I. McKeith, Newcastle-Upon-Tyne, UK; J. Haworth, Bristol, UK; D. Wilkinson, Southampton, UK; R.W. Jones, Bath, UK; A. Bayer, Penarth, UK; R.J. Smith, Bradford, UK; B. Lawlor, Dublin, Ireland; P. Crome, Stoke-on-Trent, UK; C. Bulpitt, London, UK; B. Boothman, Preston, UK; M. Evans, Chester, UK; A. Barker, Barton-on-Sea, UK; S. Simpson, Herrison, UK; A. O’Brien, Westcliff on Sea, UK; M. Doran, Fazakerley, UK; C.M. Bonthala, Northampton, UK; R. Bullock, Swindon, UK; and F.G. Inglis, Irvine, UK

Gordon Wilcock, Hilary Coles, Ian Howe and Roger Bullock assisted in trial design. Roger Bullock was an investigator in the trial. Ian Howe, Sean Lilienfeld, Luc Truyen, Hilary Coles and Young Zhu assisted in data collection. Gordon Wilcock, Ian Howes, Roger Bullock, Sean Lilienfeld, Luc Truyen and Young Zhu assisted in data analysis as well as preparation, review and final approval of the clinical trial results. All authors participated in the preparation, review and final approval of the manuscript. Young Zhu is the project statistician.

Activities related to study design, data collection and analysis, as well as preparation and review of the manuscript were funded in whole or in part by Janssen-Cilag UK, Janssen Pharmaceutica Products L.P. and Shire Pharmaceuticals Ltd. Ian Howe is an employee of Shire Pharmaceuticals Ltd; Hilary Coles is an employee of Janssen-Cilag UK; Sean Lilienfeld and Luc Truyen are employees of Janssen Pharmaceutica Products L.P.; Gordon Wilcock and Roger Bullock have received honoraria from various pharmaceutical companies for consulting and lectures.


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Copyright information

© Adis Data Information BV 2003

Authors and Affiliations

  • Gordon Wilcock
    • 1
  • Ian Howe
    • 2
  • Hilary Coles
    • 3
  • Sean Lilienfeld
    • 4
  • Luc Truyen
    • 5
  • Young Zhu
    • 5
  • Roger Bullock
    • 6
  • Paul Kershaw
    • 4
    Email author
  1. 1.Department of Care of the ElderlyUniversity of Bristol, Frenchay HospitalBristolUK
  2. 2.Shire Pharmaceuticals, Ltd., ChinehamBasingstokeUK
  3. 3.Janssen-Cilag UK, SaundertonHigh Wycombe, BuckinghamshireUK
  4. 4.Janssen Pharmaceutica Products, L.P.TitusvilleUSA
  5. 5.Johnson & Johnson Pharmaceutical Research & Development, LLCTitusvilleUSA
  6. 6.Department of Old Age Psychiatry, Kingshill Research CentreVictoria HospitalSwindonUK

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