A prospective open-label randomized comparative study in Alzheimer’s disease between two commonly used drugs in coastal Indian population

Kiran M. Haridas, Naveen Chauhan, Indrani Poddar, Kiran Poojar, Vikram Haridas, K. N. S. Rao, Kesava Pai

Abstract


Background: Currently, therapy for Alzheimer’s disease (AD) is only symptomatic. Only two classes of drugs are approved by the United States Food and Drug Administration. Our study aimed at comparing efficacy and safety of memantine and donepezil in moderate to severe AD patients.

Methods: Totally, 22 patients with moderate to severe AD were randomized into the 2 arms of the study. The study was divided into an initial 4 weeks for determination of onset of efficacy and subsequent 28 weeks of the treatment phase. Onset of efficacy and response was defined as >20% and >50% reduction in the mean total score of functional dementia scale (FDS) and clinical global impression scale (CGIS) from baseline to the study end, respectively.

Results: Onset of efficacy on FDS and CGIS was 16.7% (mean-time 61.25 days) and 80% (mean-time 36 days) with memantine and donepezil, respectively. Response was 89.3% and 40% with memantine and Donepezil, respectively. Total reduction in FDS and CGIS score of from baseline to the study end was 39.50, 40.00, and 25.60, 27.20 with memantine and donepezil, respectively. Tolerability was 86.33% and 20% with memantine and donepezil, respectively. Anorexia, muscle cramps, constipation, headache, and insomnia, were the common side-effects and self-limiting. Safety was 100% in both groups.

Conclusions: Onset of efficacy was faster with donepezil seen at 2 weeks. Response, improvement in CGIS, FDS, and tolerability were better seen with memantine at 40 weeks. Thus, in similar clinical settings, memantine can be preferred.


Keywords


Memantine, Donepezil, Alzheimer’s disease, Functional dementia scale, Clinical global impression scale

Full Text:

PDF

References


Ferri CP, Prince M, Brayne C, Brodaty H, Fratiglioni L, Ganguli M, et al. Global prevalence of dementia: a Delphi consensus study. Lancet. 2005;366(9503):2112-7.

Wimo A, Jonsson L, Winblad B. An estimate of the worldwide prevalence and direct costs of dementia in 2003. Dement Geriatr Cogn Disord. 2006;21(3):175-81.

Olin J, Schneider L. Galantamine for Alzheimer’s disease. Cochrane Database Syst Rev. 2002;(3):CD001747.

Birks J, Harvey RJ. Donepezil for dementia due to Alzheimer’s disease. Cochrane Database Syst Rev. 2006;(1):CD001190.

Qizilbash N, Whitehead A, Higgins J, Wilcock G, Schneider L, Farlow M. Cholinesterase inhibition for Alzheimer disease: a meta-analysis of the tacrine trials. Dementia Trialists’ Collaboration. JAMA. 1998;280(20):1777-82.

Forest Laboratories Inc. Prescribing information: Namenda™ tablets (memantine hydrochloride). Available at http://www.frx.com/pi/namenda. Accessed 10 October 2014.

Areosa SA, Sherriff F. Memantine for dementia. Cochrane Database Syst Rev. 2004;(4):CD003154.

Kaduszkiewicz H, Zimmermann T, Beck-Bornholdt HP, van den Bussche H. Cholinesterase inhibitors for patients with Alzheimer’s disease: systematic review of randomised clinical trials. BMJ. 2005;331(7512):321-7.

National Institute for Clinical Excellence (NICE). Donepezil, rivastigmine, galantamine, and memantine for the treatment of Alzheimer’s disease. London: NICE; 2005.

Berger G, Bernhardt T, Weimer E, Peters J, Kratzsch T, Frolich L. Longitudinal study on the relationship between symptomatology of dementia and levels of subjective burden and depression among family caregivers in memory clinic patients. J Geriatr Psychiatry Neurol. 2005;18(3):119-28.