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LATTICE研究:一项关于锂盐延缓轻度认知障碍患者认知衰退的先导可行性随机对照试验的设计

The LATTICE Study: Design of a pilot feasibility randomized controlled trial of lithium to delay cognitive decline in mild cognitive impairment.

作者信息

Gildengers Ariel G, Ibrahim Tamer S, Zeng Xuemei, Aizenstein Howard J, Alkhateeb Salem K, Anderson Stewart J, Chu Cong, Diaz Jihui L, Emanuel James E, Karikari Thomas K, Li Jinghang, Lopez Oscar L, Lopresti Brian J, Royse Sarah K, Sajewski Andrea N, Santini Tales, Weinstein Andrea M, Wu Minjie, Butters Meryl A

机构信息

Department of Psychiatry University of Pittsburgh School of Medicine Pittsburgh Pennsylvania USA.

Department of Radiology University of Pittsburgh School of Medicine Pittsburgh Pennsylvania USA.

出版信息

Alzheimers Dement (N Y). 2025 Jun 11;11(2):e70112. doi: 10.1002/trc2.70112. eCollection 2025 Apr-Jun.

DOI:10.1002/trc2.70112
PMID:40501510
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12152361/
Abstract

INTRODUCTION

Interest has grown in lithium's neuroprotective properties in neurodegenerative illnesses. We discuss the design, rationale, and implementation of a pilot feasibility, double-blind, randomized placebo-controlled trial (RCT) examining whether lithium can delay cognitive decline in older adults with mild cognitive impairment (MCI).

METHODS

The study launched in September 2017. The goal was to enroll 80 community-dwelling participants ≥ 60 years with MCI into an RCT in which they would participate for 2 years with baseline and follow-up assessment of cognition, brain imaging, and plasma-based biomarkers. Participants were randomized to lithium or placebo (1:1).

RESULTS

We enrolled 80 MCI older adults into the RCT. Baseline characteristics included a mean (standard deviation) age of 72 (7.7) years with 35 male and 45 female participants. Seventy-five participants had positron emission tomography imaging for amyloid beta (Aβ), and 66 completed 7T magnetic resonance imaging. Twenty-one participants were Aβ+ and 54 were Aβ-.

DISCUSSION

The study successfully enrolled 80 participants into an RCT examining whether lithium delays cognitive decline. The main study results will be forthcoming.

CLINICAL TRIAL REGISTRATION

NCT03185208.

HIGHLIGHTS

Eighty adults ≥ 60 years with mild cognitive impairment entered a placebo-controlled randomized controlled trial evaluating lithium's neuroprotective properties.Participants were followed for 2 years with baseline and follow-up evaluations at 1 and 2 years that included neurocognitive assessment, ultra-high-field structural neuroimaging, positron emission tomography imaging for amyloid beta and tau, and plasma-based biomarkers.Study results will be forthcoming.

摘要

引言

锂在神经退行性疾病中的神经保护特性已引发越来越多的关注。我们讨论了一项初步可行性、双盲、随机安慰剂对照试验(RCT)的设计、原理及实施情况,该试验旨在研究锂是否能延缓轻度认知障碍(MCI)老年人的认知衰退。

方法

该研究于2017年9月启动。目标是招募80名年龄≥60岁的社区居住MCI参与者进入一项RCT,他们将参与为期2年的研究,并在基线期以及第1年和第2年进行认知、脑成像和基于血浆的生物标志物的随访评估。参与者被随机分为锂组或安慰剂组(1:1)。

结果

我们将80名MCI老年人纳入了RCT。基线特征包括平均(标准差)年龄72(7.7)岁,其中男性35名,女性45名。75名参与者进行了淀粉样β蛋白(Aβ)的正电子发射断层扫描成像,66名完成了7T磁共振成像。21名参与者为Aβ阳性,54名参与者为Aβ阴性。

讨论

该研究成功招募了80名参与者进入一项RCT,以研究锂是否能延缓认知衰退。主要研究结果即将公布。

临床试验注册

NCT03185208。

要点

80名年龄≥60岁的轻度认知障碍成年人进入了一项安慰剂对照随机对照试验,评估锂的神经保护特性。对参与者进行了为期2年的随访,在基线期以及第1年和第2年进行随访评估,包括神经认知评估、超高场结构神经成像、淀粉样β蛋白和tau蛋白的正电子发射断层扫描成像以及基于血浆的生物标志物。研究结果即将公布。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d598/12152361/08b1313a08df/TRC2-11-e70112-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d598/12152361/12c80311039a/TRC2-11-e70112-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d598/12152361/aa785e09c2f5/TRC2-11-e70112-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d598/12152361/08b1313a08df/TRC2-11-e70112-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d598/12152361/12c80311039a/TRC2-11-e70112-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d598/12152361/aa785e09c2f5/TRC2-11-e70112-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d598/12152361/08b1313a08df/TRC2-11-e70112-g001.jpg

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本文引用的文献

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Am J Geriatr Psychiatry. 2025 Apr;33(4):428-437. doi: 10.1016/j.jagp.2024.09.015. Epub 2024 Oct 1.
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