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Related Experiment Videos

Donepezil therapy in clinical practice: a randomized crossover study.

S M Greenberg1, M K Tennis, L B Brown

  • 1Department of Neurology, Partners HealthCare Inc of Massachusetts General Hospital, Boston 02114, USA. greenberg@helix.mgh.harvard.edu

Archives of Neurology
|January 14, 2000
PubMed
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Donepezil hydrochloride modestly improved cognitive function in Alzheimer disease patients in a clinical setting. Cognitive scores improved during treatment, returning to baseline after drug discontinuation.

Area of Science:

  • Neurology
  • Pharmacology

Background:

  • Alzheimer disease is a progressive neurodegenerative disorder characterized by cognitive decline.
  • Donepezil hydrochloride is an acetylcholinesterase inhibitor used to treat Alzheimer disease.

Purpose of the Study:

  • To evaluate the efficacy of donepezil hydrochloride in treating Alzheimer disease in a real-world clinical practice setting.
  • To confirm findings from previous phase 3 trials.

Main Methods:

  • A two-center, randomized, placebo-controlled, double-masked crossover study was conducted.
  • Sixty patients with probable Alzheimer disease were enrolled.
  • Patients received either donepezil hydrochloride (5 mg/d) or placebo for 6 weeks, followed by a 6-week washout period.

Main Results:

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  • Cognitive subscale scores on the Alzheimer's Disease Assessment Scale improved by 2.17 points during donepezil therapy compared to placebo (P = .04).
  • Cognitive improvements returned to baseline within 3 weeks of discontinuing donepezil.
  • No significant changes were observed in caregiver-rated global impression or specific memory/fluency tests.

Conclusions:

  • Donepezil hydrochloride therapy offers a modest cognitive benefit for patients with Alzheimer disease in clinical practice.
  • The study independently confirmed efficacy data from phase 3 trials.
  • Common adverse events included nausea, diarrhea, and agitation.