Liraglutide in mild to moderate Alzheimer's disease: a phase 2b clinical trial.

In this study, we aimed to evaluate the safety and efficacy of liraglutide in mild to moderate Alzheimer's disease syndrome. 'Evaluating liraglutide in Alzheimer's disease' (ELAD) is a multicenter, randomized, double-blind, placebo-controlledphase 2b trial in 204 participants with mild to moderate Alzheimer's disease syndrome with no diabetes.

本研究旨在评估利拉鲁肽在轻度至中度阿尔茨海默病综合征患者中的安全性和有效性。'在阿尔茨海默病中评估利拉鲁肽'（ELAD）是一项多中心、随机、双盲、安慰剂对照的2b期临床试验，共有204名无糖尿病的轻度至中度阿尔茨海默病综合征患者参与。

Participants received daily injections of liraglutide or placebo for 52 weeks.

参与者接受了为期52周的利拉鲁肽或安慰剂的每日注射。

They underwent fluorodeoxyglucose positron emission tomography, magnetic resonance imaging and detailed neuropsychometric evaluations.

他们接受了氟脱氧葡萄糖正电子发射断层扫描、磁共振成像以及详细的神经心理测量评估。

The primary outcome was a change in cerebral glucose metabolic rate.

主要结果是脑葡萄糖代谢率的变化。

Secondary outcomes were safety and tolerability and cognitive changes.

次要结果是安全性和耐受性以及认知变化。

The primary outcome showed no significant differences in cerebral glucose metabolism (difference = -0.17; 95% confidence interval: -0.39 to 0.06; P = 0.14) between the two groups.

主要结果表明，两组间脑葡萄糖代谢无显著差异（差异值= -0.17；95%置信区间：-0.39至0.06；P = 0.14）

The secondary outcome-score on the Alzheimer's Disease Assessment Scale-Executive domain (ADAS-Exec)-performed better in liraglutide-treated patients compared to placebo (0.15; 95% confidence interval: 0.03-0.28; unadjusted P = 0.01).

次要结果，即阿尔茨海默病评估量表-执行功能领域（ADAS-Exec）的评分，在利拉鲁肽治疗的患者中优于安慰剂组（0.15；95%置信区间：0.03-0.28；未校正的P = 0.01）

No significant differences were observed in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) (-0.58; 95% confidence interval: -3.13 to 1.97; unadjusted P = 0.65) or Clinical Dementia Rating-Sum of Boxes (CDR-SoB) (-0.06; 95% confidence interval: -0.57 to 0.44; unadjusted P = 0.81) scores.

在阿尔茨海默病合作研究-日常生活活动(ADCS-ADL)评分(-0.58; 95%置信区间: -3.13至1.97; 未调整的P值=0.65)或临床痴呆评分-总分(CDR-SoB)评分(-0.06; 95%置信区间: -0.57至0.44; 未调整的P值=0.81)中未观察到显著差异。

Liraglutide was generally safe and well tolerated in non-diabetic patients with Alzheimer's disease.

利拉鲁肽在非糖尿病阿尔茨海默病患者中通常是安全且耐受性良好的。

ClinicalTrials.gov identifier: NCT01843075 .

ClinicalTrials.gov注册号：NCT01843075。