MINNEAPOLIS - An estrogen-like drug, raloxifene, has no demonstrated benefit on memory and thinking skills for women with dementia due to Alzheimer's disease, according to a study published in the November 4, 2015, online issue of Neurology®, the medical journal of the American Academy of Neurology.
"Drugs that interact with estrogen receptors have attracted a great deal of interest as a potential treatment for women with dementia due to Alzheimer's disease, but relatively small studies of estrogen have generally failed to confirm any benefit," said study author Victor Henderson, MD, MS, with Stanford University in Stanford, Calif., and a Fellow of the American Academy of Neurology. "Prior to this study, raloxifene had not been evaluated as an Alzheimer treatment."
For the study, 42 women with an average age of 76 with mild to moderate dementia due to Alzheimer's disease were separated into two groups and given raloxifene or a placebo pill for 12 months. The women were assessed on their memory and other mental functions at the start of the trial and then every three months. They were also evaluated on how well they could complete daily activities, and their family members or caregivers were asked about their caregiver burden and stress at the start, middle and end of the study.
Raloxifene is a type of drug known as a selective estrogen receptor modulator. It acts like estrogen in some parts of the body. In the uterus and breasts, raloxifene acts like an estrogen blocker. It is also used to prevent bone loss after menopause. An earlier study in healthy women suggested that raloxifene may lower the risk of cognitive impairment or dementia.
The results on the cognitive skills tests did not differ significantly between the placebo group and the group taking raloxifene. There were also no significant differences reported by family members and caregivers on the amount of caregiver burden or stress or in daily activities.
Henderson noted that the study was not designed to detect small effects from raloxifene in the range of that provided by approved Alzheimer's drugs such as donepezil or memantine.
"We found that the drug did not have any significant effect on patients after one year," Henderson said. "If there are cognitive effects in this population, these effects are likely to be no more than small. These results may be valuable if future trials of raloxifene are considered."
This study was supported by the National Institutes of Health. Eli Lilly provided the study drug and placebo.
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