Sleep-related outcomes in persons with mild to moderate Alzheimer disease in a placebo-controlled trial of galantamine

Sleep. 2003 Aug 1;26(5):602-6. doi: 10.1093/sleep/26.5.602.


Study objectives: To recognize the potential effect of acetylcholinesterase-inhibiting medications on sleep quality when used for the treatment of mild to moderate Alzheimer disease and describe sleep outcomes for patients treated with galantamine.

Design: This study examined sleep quality among individuals with mild to moderate Alzheimer disease using data from a 3-month, double-blind, flexible-dose trial of galantamine. The hypothesis was no difference in sleep quality between galantamine- and placebo-treated subjects.

Patients: 136 patients treated with galantamine 24 mg per day and 125 patients treated with placebo.

Measurements: Based on caregiver reports, the sleep-related outcome measures were the Pittsburgh Sleep Quality Index and the sleep disorders item from the Neuropsychiatric Inventory. Using a P-value of 0.05 (2-tailed), analysis of covariance was used to compare treatments on mean change from baseline to month 3 (Pittsburgh Sleep Quality Index) or mean score at month 3 (Neuropsychiatric Inventory), adjusted for baseline score and investigator.

Results: Both patient groups had an average age of 75 years and a mean Mini-Mental Status Examination score of 20. There were no significant differences between groups on the Pittsburgh Sleep Quality Index total (P=0.59) or subscales. For galantamine and placebo, the mean adjusted changes from baseline on the total Pittsburgh Sleep Quality Index were 0.01 and -0.17, respectively. There also was no difference on the Neuropsychiatric Inventory sleep score at month 3 (P=0.51).

Conclusions: Medications to treat Alzheimer disease should maintain sleep quality and have a neutral effect on sleep. These results further confirm the lack of sleep problems associated with galantamine treatment.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Alzheimer Disease / diagnosis
  • Alzheimer Disease / drug therapy*
  • Cholinesterase Inhibitors / adverse effects*
  • Cholinesterase Inhibitors / therapeutic use
  • Cognition Disorders / diagnosis
  • Cognition Disorders / drug therapy
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Galantamine / adverse effects*
  • Galantamine / therapeutic use
  • Humans
  • Male
  • Prevalence
  • Severity of Illness Index
  • Sleep Wake Disorders / chemically induced*
  • Sleep Wake Disorders / diagnosis
  • Sleep Wake Disorders / epidemiology


  • Cholinesterase Inhibitors
  • Galantamine