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Baseline Differences in Long-term Survivors and Nonsurvivors of the Colorado/Columbia Fetal Implant Trial
Journal of the International Neuropsychological Society ( IF 2.6 ) Pub Date : 2021-06-14 , DOI: 10.1017/s1355617721000680
Cynthia McRae 1 , Michelle Dunk 2 , Dan Russell 3 , Heiner Ellgring 4 , Yaakov Stern 5 , Paul Greene 6 , Stanley Fahn 7 , Claire Henchcliffe 8
Affiliation  

Objective:

This study is based on long-term follow-up of participants in a randomized double-blind sham surgery-controlled trial (1995–1999) designed to determine the effectiveness of implantation of human embryonic mesencephalic tissue containing dopamine neuron precursors into the brains of patients with advanced Parkinson’s disease (PD). We investigated differences between long-term survivors and nonsurvivors at baseline in order to contribute to information regarding optimal patient selection for upcoming stem cell trials.

Method:

Forty participants were randomly assigned to receive either neural implantation or sham surgery. Thirty-four patients who ultimately received the implant were followed periodically with the most recent assessment occurring in 2015–2016. Demographic information, neurological measures, positron emission tomography (PET) imaging, neuropsychological assessments, and a personality assessment were included in the current analyses. T-tests were used to compare survivors and nonsurvivors. Logistic regression analyses examined predictors of survivorship.

Results:

Five of six survivors were female. They were younger than nonsurvivors (p = .03) and more neuropsychologically “intact” across a broad range of cognitive areas (significance levels ranged from <.001 to .045). There were no differences between survivors and nonsurvivors off medications at baseline on neurological or PET assessments. Survivors reported more “Openness to Experience” (p = .004) than nonsurvivors. Using empirically derived predictor variables, results of logistic regression analyses indicated that Animal Naming (cognitive task) and Openness to Experience (personality variable) were the strongest predictors of survivorship.

Conclusions:

Variables to consider when selecting participants for future cell-based therapies include being “intact” neuropsychologically, level of Openness to Experience, younger age, and inclusion of women.



中文翻译:

科罗拉多/哥伦比亚胎儿植入试验的长期幸存者和非幸存者的基线差异

客观的:

本研究基于对随机双盲假手术对照试验(1995-1999)参与者的长期随访,该试验旨在确定将含有多巴胺神经元前体的人类胚胎中脑组织植入患者大脑的有效性患有晚期帕金森病(PD)。我们调查了基线时长期幸存者和非幸存者之间的差异,以便为即将进行的干细胞试验提供有关最佳患者选择的信息。

方法:

四十名参与者被随机分配接受神经植入或假手术。对最终接受植入物的 34 名患者进行了定期随访,最近一次评估发生在 2015-2016 年。目前的分析包括人口统计信息、神经学测量、正电子发射断层扫描 (PET) 成像、神经心理学评估和人格评估。T检验用于比较幸存者和非幸存者。逻辑回归分析检查了生存的预测因素。

结果:

六名幸存者中有五名是女性。他们比非幸存者年轻 ( p = .03),并且在广泛的认知领域(显着性水平从 <.001 到 0.045)在神经心理上更加“完整”。在神经学或 PET 评估的基线上,幸存者和非幸存者在停药时没有差异。幸存者比非幸存者报告了更多的“经验开放性”(p = .004)。使用经验派生的预测变量,逻辑回归分析的结果表明,动物命名(认知任务)和开放性经验(人格变量)是生存的最强预测因子。

结论:

在为未来的细胞疗法选择参与者时要考虑的变量包括神经心理学上的“完整”、对经验的开放程度、年龄较小和女性的包容性。

更新日期:2021-06-14
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