Donepezil significantly improves abilities in daily lives of female Down syndrome patients with severe cognitive impairment: a 24-week randomized, double-blind, placebo-controlled trial

Int J Psychiatry Med. 2011;41(1):71-89. doi: 10.2190/PM.41.1.g.


Objective: Down syndrome (DS) patients share certain neuropathological features with Alzheimer disease patients. A randomized, double-blind, placebo-controlled study was performed to investigate the efficacy and safety of donepezil, an Alzheimer disease drug, for DS patients.

Method: Twenty-one DS patients with severe cognitive impairment were assigned to take donepezil (3 mg daily) or a placebo for 24 weeks, and evaluated for activities in daily lives by concisely modified International Classification of Functioning, Disability and Health (ICF) scaling system.

Results: ICF scores significantly increased without any adverse effects in the donepezil group in comparison to those in the placebo control. Among the individual functions tested, there was a dramatic improvement in the global mental functions and in specific mental functions.

Conclusions: Donepezil may effectively and safely improve overall functioning of DS patients with severe cognitive impairment.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Activities of Daily Living*
  • Adult
  • Cognition Disorders / complications
  • Cognition Disorders / drug therapy*
  • Donepezil
  • Double-Blind Method
  • Down Syndrome / complications
  • Down Syndrome / drug therapy*
  • Female
  • Humans
  • Indans / therapeutic use*
  • Middle Aged
  • Neuropsychological Tests
  • Nootropic Agents / therapeutic use*
  • Piperidines / therapeutic use*
  • Quality of Life
  • Treatment Outcome


  • Indans
  • Nootropic Agents
  • Piperidines
  • Donepezil