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dementiaOctober 28 2015

Withdrawing donepezil from patients with moderate to severe Alzheimer’s disease can double the risk of patients being admitted to a nursing home within a year.

The effect is seen in the first 12 months in comparison to patients continuing with donepezil and/or memantine, but no difference in nursing home admissions is seen between patient groups in the following three years.

Results of the randomised, double-blind, placebo-controlled Donepezil and Memantine in Moderate to Severe Alzheimer's Disease (DOMINO-AD) trial have been published in The Lancet Neurology. Patients were selected with moderate-to-severe Alzheimer’s disease who had been prescribed donepezil continuously for at least three months at a dose of 10mg for at least the previous six weeks and had a score of between 5 and 13 on the Standardised Mini-Mental State Examination.

At the start of the trial, patients were all living in the community and were randomly assigned to four different groups:

  • 73 (25%) to continue donepezil 10mg daily without memantine
  • 73 (25%) to discontinue donepezil without memantine
  • 76 (26%) to discontinue donepezil and start memantine 20mg daily, and
  • 73 (25%) to continue donepezil 10mg and start memantine 20mg daily.

After 12 months, choice of treatment was left to participants and their doctor, and place of residence was recorded at 12 months and then every six months subsequently. A total of 162 patients underwent nursing home placement during the four years of the study.

“We noted significant (p=0·010) heterogeneity of treatment effect over time, with significantly more nursing home placements in the combined donepezil discontinuation groups during the first year (hazard ratio 2·09 [95% CI 1·29–3·39]) than in the combined donepezil continuation groups, and no difference during the next three years (0·89 [0·58–1·35]),” say the authors from University College London.

“Decisions to stop or continue donepezil treatment should be informed by potential risks of withdrawal, even if the perceived benefits of continued treatment are not clear.”

Dr Kathryn Adcock, head of neurosciences and mental health at the Medical Research Council, commented: “This study provides strong evidence that donepezil can benefit people in the more severe stages of Alzheimer’s disease for longer than was expected.”

The MRC estimates that 527,000 people are living with Alzheimer’s disease, the most common form of dementia, and around 58,600 people with mild-to-moderate Alzheimer’s disease are currently taking donepezil.

Links:

R Howard et al. ‘Nursing home placement in the Donepezil and Memantine in Moderate to Severe Alzheimer's Disease (DOMINO-AD) trial: secondary and post-hoc analyses’. The Lancet Neurology. Published online October 26 2015.

MRC statement

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