1 However, gender has not yet been adequately addressed in clinical trials. Even regarding the difference in longevity, studies suggest that women are still at a higher risk. Trial Registration Identifier: NCT02103673Īge and female gender are 2 major risk factors for Alzheimer disease (AD) two-thirds of older adults with AD are women. In the future, longer dose-finding trials are warranted to further clarify the efficacy of benzoate for later-phase dementia and investigate the role of sex hormones and other factors in the pathogenesis of dementia. Compared with placebo, benzoate treatment also increased estradiol to follicle-stimulating hormone ratios among women (mean difference between baseline and end point, 0 vs −0.1 P = .03).Ĭonclusions and Relevance These findings suggest that benzoate treatment may improve cognitive function in women with later-phase dementia. In contrast, among 35 men, the 2 treatment groups did not differ significantly in both ADAS-cog and BEHAVE-AD scores. Among 62 women, 6-week benzoate treatment significantly surpassed placebo in the effects on ADAS-cog performance (mean difference in score between baseline and end point, −3.1 points vs 0 points Cohen d = 0.56 P = .04) but not BEHAVE-AD performance. Results Among 97 total participants (62 women mean age, 75.4 years), 49 patients (30 women and 19 men) were randomized to sodium benzoate, and 48 (32 women and 16 men) were randomized to placebo. Main Outcomes and Measures The primary outcome measures were Alzheimer disease assessment scale–cognitive subscale (ADAS-cog) and Behavioral Pathology in Alzheimer Disease Rating Scale (BEHAVE-AD) scores. Interventions Six weeks of treatment of 250 to 1500 mg/d of sodium benzoate or placebo. Data were analyzed between February 2014 and November 2017. Objective To examine the potential gender difference in the effects of benzoate treatment on the behavioral and psychological symptoms of dementia (BPSD).ĭesign, Setting, and Participants This post hoc secondary analysis used data from a randomized, double-masked, placebo-controlled trial conducted in 3 major medical centers in Taiwan and enrolled 97 patients with BPSD. A recent study demonstrated that sodium benzoate, a D-amino acid oxidase inhibitor, improved cognitive function in early-phase Alzheimer disease. Importance Female gender is a major risk factor for dementia however, gender has not yet been adequately addressed by clinical trials.
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