Study rationale and baseline data for pilot trial of dronabinol adjunctive treatment of agitation in Alzheimer's dementia (THC-AD).

IF 5.4 3区材料科学 Q2 CHEMISTRY, PHYSICAL

ACS Applied Energy Materials Pub Date : 2024-12-01 Epub Date: 2021-10-11 DOI:10.1017/S1041610221001150

Leah M Cohen, Eleanor Ash, John D Outen, Ryan Vandrey, Halima Amjad, Marc Agronin, M Haroon Burhanullah, Patricia Walsh, James M Wilkins, Jeannie-Marie Leoutsakos, Milap A Nowrangi, David Harper, Paul B Rosenberg, Brent P Forester

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引用次数: 0

Abstract

Agitation is a common complication of Alzheimer's dementia (Agit-AD) associated with substantial morbidity, high healthcare service utilization, and adverse emotional and physical impact on care partners. There are currently no FDA-approved pharmacological treatments for Agit-AD. We present the study design and baseline data for an ongoing multisite, three-week, double-blind, placebo-controlled, randomized clinical trial of dronabinol (synthetic tetrahydrocannabinol [THC]), titrated to a dose of 10 mg daily, in 80 participants to examine the safety and efficacy of dronabinol as an adjunctive treatment for Agit-AD. Preliminary findings for 44 participants enrolled thus far show a predominately female, white sample with advanced cognitive impairment (Mini Mental Status Examination mean 7.8) and agitation (Neuropsychiatric Inventory-Clinician Agitation subscale mean 14.1). Adjustments to study design in light of the COVID-19 pandemic are described. Findings from this study will provide guidance for the clinical utility of dronabinol for Agit-AD. ClinicalTrials.gov Identifier: NCT02792257.

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屈大麻酚辅助治疗阿尔茨海默氏症痴呆症（THC-AD）躁动试点试验的研究原理和基线数据。

躁动是阿尔茨海默氏症痴呆症（Agit-AD）的常见并发症，具有发病率高、医疗服务使用率高、对护理伙伴的情绪和身体造成不良影响等特点。目前，美国食品和药物管理局（FDA）尚未批准针对躁动性痴呆症（AD）的药物治疗。我们介绍了一项正在进行中的多地点、为期三周、双盲、安慰剂对照、随机临床试验的研究设计和基线数据，该试验采用屈大麻酚（合成四氢大麻酚 [THC]），每日剂量为 10 毫克，共 80 人参加，目的是考察屈大麻酚作为躁动综合征辅助治疗的安全性和有效性。迄今为止，44 名参与者的初步研究结果显示，他们主要为女性、白人，认知障碍（迷你精神状态检查平均值为 7.8）和躁动（神经精神量表-医师躁动分量表平均值为 14.1）均已达到晚期程度。本文介绍了根据 COVID-19 大流行对研究设计所做的调整。这项研究的结果将为屈大麻酚治疗躁动-AD的临床应用提供指导。ClinicalTrials.gov Identifier：NCT02792257。

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来源期刊

ACS Applied Energy Materials Materials Science-Materials Chemistry

CiteScore

10.30

自引率

6.20%

发文量

1368

期刊介绍： ACS Applied Energy Materials is an interdisciplinary journal publishing original research covering all aspects of materials, engineering, chemistry, physics and biology relevant to energy conversion and storage. The journal is devoted to reports of new and original experimental and theoretical research of an applied nature that integrate knowledge in the areas of materials, engineering, physics, bioscience, and chemistry into important energy applications.