Sešok Sanja, Bolle Nika, Kobal Jan, Bucik Valentin, Vodušek David B
Division of Neurology, University Medical Centre Ljubljana, Zaloška 2, 1000 Ljubljana, Slovenia,
Psychiatr Danub. 2014 Sep;26(3):239-48.
In Huntington disease (HD) patients receiving rivastigmine treatment improvement of behavioral symptoms and of cognitive function (assessed with screening diagnostic instruments) has been reported. The aim of the present study was to verify such improvement in cognitive function by cognitive function assessment with a detailed neuropsychological battery covering all relevant cognitive systems expected to be impaired in early phase HD.
Eighteen (18) HD patients entered the study and were randomly allocated to the rivastigmine and placebo group. All subjects underwent neuropsychological assessment at baseline. Follow-up neuropsychological assessment was applied after 6 months of rivastigmine or placebo treatment. Eighteen (18) healthy controls entered the study to control for practice effect and underwent neuropsychological assessment at baseline and after 6 months, without treatment. The neuropsychological battery consisted of assessment tools that are sensitive to cognitive impairment seen in early phase HD: CTMT, SDMT, Stroop (attention and information control), RFFT, TOL, Verbal fluency (executive functioning), CVLT-II, RCFT (learning and memory). Effect of rivastigmine and possible effect of practice was assessed using the mixed ANOVA model.
No statistically significant effect of rivastigmine treatment on cognitive function in HD patients was detected. There was no evidence for practice or placebo effect.
Detailed neuropsychological assessment did not confirm previously reported effect of rivastigmine treatment on cognitive function in HD patients. The limitations of our study are, in particular, small sample size and the lack of a single measure of relevant cognitive functioning in HD patients. Instead of focusing solely on statistical significance, a clinical relevance study is proposed to clarify the issue of rivastigmine effects in HD.
据报道,接受卡巴拉汀治疗的亨廷顿病(HD)患者的行为症状和认知功能(通过筛查诊断工具评估)有所改善。本研究的目的是通过使用涵盖早期HD预计受损的所有相关认知系统的详细神经心理测验来评估认知功能,以验证这种认知功能的改善情况。
18名HD患者进入本研究,并被随机分配到卡巴拉汀组和安慰剂组。所有受试者在基线时均接受神经心理评估。在接受卡巴拉汀或安慰剂治疗6个月后进行随访神经心理评估。18名健康对照者进入本研究以控制练习效应,并在基线时和6个月后未接受治疗的情况下接受神经心理评估。神经心理测验包括对早期HD中所见认知障碍敏感的评估工具:CTMT、SDMT、Stroop(注意力和信息控制)、RFFT、TOL、言语流畅性(执行功能)、CVLT-II、RCFT(学习和记忆)。使用混合方差分析模型评估卡巴拉汀的效果和可能的练习效果。
未检测到卡巴拉汀治疗对HD患者认知功能有统计学显著影响。没有证据表明存在练习效应或安慰剂效应。
详细的神经心理评估未证实先前报道的卡巴拉汀治疗对HD患者认知功能的影响。我们研究的局限性尤其在于样本量小以及缺乏对HD患者相关认知功能的单一测量。建议开展一项临床相关性研究,而不是仅关注统计学意义,以阐明卡巴拉汀在HD中的作用问题。