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

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.