Central Laboratory, Tianjin Fifth Central Hospital (Peking University Binhai Hospital), Tianjin, China.
Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.
J Alzheimers Dis. 2024;99(4):1173-1186. doi: 10.3233/JAD-240161.
Early intervention is essential for meaningful disease modification in Alzheimer's disease (AD).
We aimed to determine the efficacy and safety of pharmacologic and nutritional interventions for early AD.
PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov were searched from database inception until 1 September 2023. We included randomized controlled trials that evaluated the efficacy of interventions in early AD. Only interventions that demonstrated efficacy compared to placebo were included in the network meta-analysis (NMA). Then we performed frequentist fixed-effects NMA to rank the interventions. GRADE criteria were used to evaluate the level of evidence.
Fifty-eight trials including a total of 33,864 participants and 48 interventions were eligible for inclusion. Among the 48 interventions analyzed, only 6 (12.5%) treatments- ranging from low to high certainty- showed significant improvement in cognitive decline compared to placebo. High certainty evidence indicated that donanemab (standardized mean difference [SMD] -0.239, 95% confidence interval [CI] -0.343 to -0.134) and lecanemab (SMD -0.194, 95% CI -0.279 to -0.108) moderately slowed the clinical progression in patients with amyloid pathology. Additionally, methylphenidate, donepezil, LipiDiDiet, and aducanumab with low certainty showed significant improvement in cognitive decline compared to placebo. However, there was no significant difference in serious adverse events as reported between the six interventions and placebo.
Only 12.5% of interventions studied demonstrated efficacy in reducing cognitive impairment in early AD. Donanemab and lecanemab have the potential to moderately slow the clinical progression in patients with amyloid pathology. Further evidence is required for early intervention in AD.
对于阿尔茨海默病(AD)的有意义的疾病修饰,早期干预至关重要。
我们旨在确定药物和营养干预对早期 AD 的疗效和安全性。
从数据库建立到 2023 年 9 月 1 日,我们在 PubMed、Embase、Cochrane 图书馆和 ClinicalTrials.gov 上进行了搜索。我们纳入了评估早期 AD 干预效果的随机对照试验。只有与安慰剂相比显示出疗效的干预措施才被纳入网络荟萃分析(NMA)。然后,我们进行了固定效应 NMA 来对干预措施进行排名。使用 GRADE 标准评估证据水平。
共有 58 项试验(共纳入 33864 名参与者和 48 项干预措施)符合纳入标准。在分析的 48 项干预措施中,只有 6 项(占 12.5%)治疗方法(从低到高的确定性)与安慰剂相比,认知衰退有显著改善。高确定性证据表明,多那美单抗(标准化均数差 [SMD] -0.239,95%置信区间 [CI] -0.343 至 -0.134)和利纳西单抗(SMD -0.194,95% CI -0.279 至 -0.108)在淀粉样蛋白病理患者中适度减缓了临床进展。此外,哌醋甲酯、多奈哌齐、LipiDiDiet 和阿杜卡奴单抗的认知衰退改善与安慰剂相比具有低确定性。然而,在六组干预措施与安慰剂之间,报告的严重不良事件没有显著差异。
只有 12.5%的研究干预措施显示在减少早期 AD 的认知障碍方面有效。多那美单抗和利纳西单抗有可能适度减缓淀粉样蛋白病理患者的临床进展。需要进一步的证据来支持 AD 的早期干预。