Zhang Ying, Zhou Junyi, Gehl Carissa R, Long Jeffrey D, Johnson Hans, Magnotta Vincent A, Sewell Daniel, Shannon Kathleen, Paulsen Jane S
Department of Biostatistics, College of Public Health, University of Nebraska Medical Center, Omaha, NE, United States.
Department of Biostatistics, Indiana University Fairbanks School of Public Health, Indianapolis, IN, United States.
Front Neurol. 2021 Jul 7;12:678652. doi: 10.3389/fneur.2021.678652. eCollection 2021.
As one of the clinical triad in Huntington's disease (HD), cognitive impairment has not been widely accepted as a disease stage indicator in HD literature. This work aims to study cognitive impairment thoroughly for prodromal HD individuals with the data from a 12-year observational study to determine whether Mild Cognitive Impairment (MCI) in HD gene-mutation carriers is a defensible indicator of early disease. Prodromal HD gene-mutation carriers evaluated annually at one of 32 worldwide sites from September 2002 to April 2014 were evaluated for MCI in six cognitive domains. Linear mixed-effects models were used to determine age-, education-, and retest-adjusted cut-off values in cognitive assessment for MCI, and then the concurrent and predictive validity of MCI was assessed. Accelerated failure time (AFT) models were used to determine the timing of MCI (single-, two-, and multiple-domain), and dementia, which was defined as MCI plus functional loss. Seven hundred and sixty-eight prodromal HD participants had completed all six cognitive tasks, had MRI, and underwent longitudinal assessments. Over half (i.e., 54%) of the participants had MCI at study entry, and half of these had single-domain MCI. Compared to participants with intact cognitive performances, prodromal HD with MCI had higher genetic burden, worsened motor impairment, greater brain atrophy, and a higher likelihood of estimated HD onset. Prospective longitudinal study of those without MCI at baseline showed that 48% had MCI in subsequent visits and data visualization suggested that single-domain MCI, two-domain MCI, and dementia represent appropriate cognitive impairment staging for HD gene-mutation carriers. Findings suggest that MCI represents an early landmark of HD and may be a sensitive enrichment variable or endpoint for prodromal clinical trials of disease modifying therapeutics.
作为亨廷顿舞蹈症(HD)临床三联征之一,认知障碍在HD文献中尚未被广泛接受为疾病阶段指标。这项研究旨在通过一项为期12年的观察性研究数据,对前驱期HD个体的认知障碍进行深入研究,以确定HD基因突变携带者的轻度认知障碍(MCI)是否是早期疾病的可靠指标。对2002年9月至2014年4月期间在全球32个地点之一每年接受评估的前驱期HD基因突变携带者,在六个认知领域进行MCI评估。使用线性混合效应模型确定MCI认知评估中经年龄、教育程度和复测调整后的临界值,然后评估MCI的同时效度和预测效度。使用加速失效时间(AFT)模型确定MCI(单领域、双领域和多领域)以及痴呆症(定义为MCI加功能丧失)的发生时间。768名前驱期HD参与者完成了所有六项认知任务,进行了MRI检查,并接受了纵向评估。超过一半(即54%)的参与者在研究开始时患有MCI,其中一半患有单领域MCI。与认知表现正常的参与者相比,患有MCI的前驱期HD患者具有更高的遗传负担、更严重的运动障碍、更大的脑萎缩以及更高的HD发病估计可能性。对基线时无MCI的患者进行的前瞻性纵向研究表明,48%的患者在后续随访中出现MCI,数据可视化显示单领域MCI、双领域MCI和痴呆症代表了HD基因突变携带者适当的认知障碍分期。研究结果表明,MCI是HD的早期标志,可能是疾病修饰疗法前驱期临床试验的敏感富集变量或终点。