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Trial shows no cognitive benefit of raloxifene for women with Alzheimer's disease

Results from a randomized, double-blind, placebo-controlled trial indicate raloxifene had no cognitive benefits for women with Alzheimer’s disease.

“The burden of Alzheimer’s disease falls heavily on women. By virtue of greater longevity, more women than men survive to an older age when risk is greater. [Alzheimer’s disease] pathology is more likely to be expressed as dementia in women than men, and cognitive symptoms appear to be more severe,” Victor W. Henderson, MD, MS, of Stanford University, California, and colleagues wrote. “Estrogens have attracted interest as potential treatment for women with [Alzheimer’s disease], but relatively small therapeutic trials have generally failed to confirm efficacy.”

To determine if raloxifene improved cognitive function among women with Alzheimer’s disease, researchers randomly assigned women with mild to moderately severe late-onset Alzheimer’s disease to 120 mg of raloxifene (n = 21) or placebo (n = 21) once daily. Researchers compared Alzheimer’s Disease Assessment Scale, cognitive subscale scores at 12 months. Women had a mean age of 76 years.

Alzheimer’s Disease Assessment Scale, cognitive subscale scores did not significantly differ between treatment groups (standardized difference = 0.03; P = .89).

Dementia rating, daily living activities, behavior and global cognition composite scores were also not significantly different between groups.

Caregiver burden and distress were similar among treatment groups.

“These results provide information to guide consideration and design of future trials. The essentially null effect of raloxifene on the primary outcome implies a low likelihood of positive results but does not exclude the possibility of modest cognitive benefit or harm,” Henderson and colleagues wrote. “We conclude that 12 months’ treatment with raloxifene 120 mg/day compared with placebo has no more than a small effect on the [Alzheimer’s Disease Assessment Scale, cognitive subscale] in women with late-onset [Alzheimer’s disease] of mild-to-moderate severity. This conclusion may not pertain to short-term (eg, 3-month) effects of raloxifene, where we found a nominally significant difference between groups on the [Alzheimer’s Disease Assessment Scale, cognitive subscale]; to effects that might require more than 12 months to emerge; or to selective effects within specific cognitive domains.” – by Amanda Oldt

Disclosure: Henderson reports receiving research support from the NIH. Please see the full study for a list of all authors’ relevant financial disclosures.