A Double-Blind,Placebo-Controlled Trial of Donepezil for the Treatment of Menopause-Related Cognitive Loss |
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| Affiliation: | 1. The New York Memory and Healthy Aging Services, New York, New York;2. Departments of Medicine (Neurology) and Psychiatry, Lenox Hill Hospital, New York, New York;3. Department of Neurology, New York University School of Medicine, New York, New York;1. Patient Safety Research Centre, Urmia University of Medical Sciences, Urmia, Iran;2. Faculty of Nursing, Tabriz University of Medical Sciences, Tabriz, Iran;3. Faculty of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran;4. Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran;5. Department of Biostatistics, Urmia University of Medical Sciences, Urmia, Iran;1. Physician, Gynecology and Obstetrics, Facultad de Medicina, Grupo de Investigación Salud de la Mujer, Facultad de Medicina, Universidad de Cartagena, Colombia;2. Physician, Grupo de Investigación Salud de la Mujer, Facultad de Medicina, Universidad de Cartagena, Colombia;3. Student, Facultad de Medicina, Grupo de Investigación Salud de la Mujer, Facultad de Medicina. Universidad de Cartagena, Colombia;1. Unit for Social and Community Psychiatry, WHO Collaborative Centre for Mental Health Services Development, Barts and the London School of Medicine, Queen Mary University of London, Newham Centre for Mental Health, United Kingdom;2. Institute of Psychological Medicine and Clinical Neurosciences, Cardiff University, Cardiff, United Kingdom;3. Epilepsy Ireland, Dublin, Ireland;4. School of Psychology, University College Dublin, Ireland;5. Tizard Centre, University of Kent, Canterbury, Kent, United Kingdom;6. School of Social Work and Social Policy, Trinity College Dublin, Ireland;1. Sleep Medicine Section, Neurology Service, Hospital Italiano de Buenos Aires, Argentina;2. Climacteric Department at the Italian Hospital of Buenos Aires, Argentina;3. Obstetrics Service, Hospital Italiano de Buenos Aires, Argentina;4. Clinical Institute of Gynecology, Obstetrics and Neonatology, Faculty of Medicine-University of Barcelona, Hospital Clinic-Institut d´Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain |
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| Abstract: | Background: Perimenopausal and menopausal women are more likely to complain of memory loss than are premenopausal women, although the association between menopause and cognitive loss remains controversial. Recently published studies on the risks of hormone therapy have left many women and their physicians seeking effective nonhormonal treatments for menopausal symptoms, including cognitive loss.Objective: This study investigated the efficacy of the cholinesterase agent donepezil in the treatment of menopause-related cognitive loss.Methods: Community-dwelling women in natural menopause were recruited for a randomized, double-blind, placebo-controlled study of donepezil. To qualify for enrollment, the Brief Cognitive Rating Scale was used to determine cognitive symptoms, and women with depression were excluded. Subjects were randomized to receive either donepezil, commencing at 5 mg/d, or placebo. At week 6 of randomization, the dosage of donepezil was increased to 10 mg/d. Treatment continued throughout the 26-week study. The primary outcome measure was the overall change in neurocognitive test results over time. Outcome variables of test scores were analyzed before and after receipt of donepezil or placebo.Results: A total of 28 women aged 46 to 60 years were enrolled. Fourteen women were randomized to receive active drug, 14 to placebo. Two women dropped out of the placebo group. There were no statistically significant differences between treatment groups in post-/pre-dose mean score ratios. No interactions were statistically significant. The P values for tests of equal variances did not reveal a difference in the means. Subjective measures did show some trends toward improvement in memory and cognition.Conclusion: Donepezil was no more effective than placebo in treating the symptoms of menopause- related memory and cognitive loss. |
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