Supplementary Material for: Souvenaid Reduces Behavioral Deficits and Improves Social Cognition Skills in Frontotemporal Dementia: A Proof-of-Concept Study

Background: Souvenaid™ is a nutraceutical compound thought to positively enhance synaptic function. In line with this mechanism of action, Souvenaid™ has been shown to improve cognitive function in subjects with mild Alzheimer's disease in randomized clinical trials. To date, however, the potential of Souvenaid™ to improve cognitive functioning in subjects with other neurodegenerative conditions also characterized by synaptic loss has not been explored. Objective: To evaluate the impact of Souvenaid™ on executive functions, social cognition and behavioral disturbances in subjects with the behavioral variant of frontotemporal dementia (bv-FTD). Methods: Twenty-six subjects with bv-FTD were enrolled in the study and randomized to Souvenaid™ (125 ml/day) or placebo groups. After 12 weeks, subjects were switched between the two groups. All subjects, blinded to treatment, underwent clinical and cognitive evaluations at enrollment, after 12 weeks and after 24 weeks. Results: Treatment with Souvenaid™ was associated with a significant reduction of behavioral symptoms and an increase in Theory of Mind skills compared to placebo, which both returned to baseline when Souvenaid™ was discontinued. Souvenaid™ did not have an effect on executive functions. Conclusions: Our results provide evidence of the potential of Souvenaid™ therapy for the treatment of behavioral disturbances and social cognition skills in FTD.

背景：Souvenaid™是一种被认为可正向增强突触功能的营养保健化合物。基于这一作用机制，Souvenaid™在随机对照临床试验中已被证实可改善轻度阿尔茨海默病受试者的认知功能。但迄今为止，Souvenaid™在其他以突触丢失为特征的神经退行性疾病受试者中改善认知功能的潜力尚未得到探索。
目的：本研究旨在评估Souvenaid™对行为变异型额颞叶痴呆（behavioral variant frontotemporal dementia, bv-FTD）受试者的执行功能、社会认知及行为障碍的影响。
方法：本研究共纳入26名bv-FTD受试者，将其随机分为Souvenaid™组（每日给药125ml）与安慰剂组。干预12周后，两组受试者交叉更换干预方案。所有受试者均对治疗方案不知情，分别于入组时、干预12周后及24周后接受临床与认知评估。
结果：与安慰剂组相比，Souvenaid™治疗可显著减轻行为症状，并提升心理理论（Theory of Mind）能力；停用Souvenaid™后，上述两项改善均回归至基线水平。Souvenaid™对执行功能无显著影响。
结论：本研究结果证实，Souvenaid™疗法有望用于治疗FTD患者的行为障碍并改善其社会认知能力。