从 "节省的时间 "角度评估 Fortasyn Connect 的临床意义

Samuel Dickson, A. Solomon, M. Kivipelto, T. Hartmann, A. M. J. van Hees, A. Brownlee, B. Haaland, C. H. Mallinckrodt, S. B. Hendrix
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引用次数: 0

摘要

阿尔茨海默病(AD)随机临床试验(RCT)的意义评估具有挑战性,尤其是在疾病早期。将临床结果转换为疾病进展时间,可以使用一种易于理解且有意义的指标(时间)来评估治疗效果。我们在 LipiDiDiet 多营养素临床试验中展示了使用元时间成分测试(TCT)进行的时间节省评估。膳食模式对预防痴呆症非常重要,这可能是由于个别营养素的累积效应。LipiDiDiet 采用多营养素(Fortasyn Connect)配方,对阿兹海默症前驱期患者的认知(5 项复合 NTB,效应 0.089)、认知和功能(CDR-SB,-0.605)均有益处,并能减缓海马萎缩(0.122 cm3)。点差异的意义尚不明确。不过,综合 TCT 显示,在 24 个月时可节省 9 个月的患病时间(患病时间减缓 38%):在NTB、CDR-SB和海马体积方面,分别节省了9.0、10.5和7.2个月的时间,这凸显了TCT在AD RCT中的价值以及继续验证这种方法的必要性。
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Evaluation of Clinical Meaningfulness of Fortasyn Connect in Terms of “Time Saved”

Assessment of meaningfulness in randomized clinical trials (RCTs) in Alzheimer’s disease (AD) is challenging, particularly in early disease. Converting clinical outcomes to disease progression time allows assessment of treatment effects using a metric that is understandable and meaningful: time. We demonstrate time savings assessments using meta time component tests (TCTs) in the LipiDiDiet multinutrient RCT. Dietary patterns are important for dementia prevention, likely due to individual cumulative nutrient effects. LipiDiDiet used a multinutrient (Fortasyn Connect) formulation in patients with prodromal AD, benefitting cognition (5-item composite NTB, effect 0.089), cognition and function (CDR-SB, −0.605), and slowing hippocampal atrophy (0.122 cm3). Meaningfulness of point differences is unclear. However, a combination TCT showed 9-month disease time savings at 24 months (38% slowing of disease time): 9.0, 10.5, and 7.2 months for NTB, CDR-SB, and hippocampal volume, underscoring the value of TCTs in AD RCTs and the need for continued validation of this approach.

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来源期刊
The Journal of Prevention of Alzheimer's Disease
The Journal of Prevention of Alzheimer's Disease Medicine-Psychiatry and Mental Health
CiteScore
9.20
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期刊介绍: The JPAD Journal of Prevention of Alzheimer’Disease will publish reviews, original research articles and short reports to improve our knowledge in the field of Alzheimer prevention including: neurosciences, biomarkers, imaging, epidemiology, public health, physical cognitive exercise, nutrition, risk and protective factors, drug development, trials design, and heath economic outcomes.JPAD will publish also the meeting abstracts from Clinical Trial on Alzheimer Disease (CTAD) and will be distributed both in paper and online version worldwide.We hope that JPAD with your contribution will play a role in the development of Alzheimer prevention.
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