Nighttime Agitation and Restless Legs Syndrome in Persons With Alzheimer's Disease: Study Protocol for a Double-Blind, Placebo-Controlled, Randomized Trial (NightRest).
Nighttime Agitation and Restless Legs Syndrome in Persons With Alzheimer's Disease: Study Protocol for a Double-Blind, Placebo-Controlled, Randomized Trial (NightRest).
复制标题
DOI：
10.3928/19404921-20200918-01
复制
发表时间：
2020-11-01
影响因子：
1.6
通讯作者：
Allen, Richard
中科院分区：
文献类型：
--
作者：
Richards, Kathy;Morrison, Janet;Wang, Yan-Yan;Rangel, Angelica;Loera, Ana;Hanlon, Alexandra;Lozano, Alicia;Kovach, Christine;Gooneratne, Nalaka;Fry, Liam;Allen, Richard
夜间躁动是阿尔茨海默病（AD）患者的一种常见症状。由于我们对其病因学的了解有限，缺乏有效的治疗方法。我们假设，不宁腿综合征（RLS），一种常见的神经感觉运动障碍的不舒服的腿的感觉，出现在夜间和干扰睡眠，可能是一个原因，夜间躁动的人与AD。RLS在AD患者中很少被发现，因为传统的诊断依赖于患者回答有关其症状的复杂问题。通过一种有效的RLS诊断观察工具，行为指标测试-不宁腿，我们旨在诊断RLS并确定FDA批准的RLS药物加巴喷丁enacarbil（GEn）与安慰剂相比对夜间躁动，睡眠，抗精神病药物的影响以及这些影响的机制。我们假设RLS行为的频率将介导GEn和夜间躁动之间的关系。这项研究是一项为期8周的双盲、安慰剂对照、随机化初步临床试验，随后是一项为期8周的开放标签试验，正在长期护理（LTC）环境和私人家庭中进行。这项研究的结果可能会改变，个性化和改善夜间躁动治疗的护理标准;减少攻击和其他夜间躁动行为;并改善睡眠。临床Trials.gov标识符：NCT 03082755（注册日期：2017年3月6日）
Nighttime agitation is a prevalent symptom in persons with Alzheimer’s disease (AD). Effective treatments are absent due to our limited knowledge of its etiology. We hypothesized that restless legs syndrome (RLS), a common neurologic sensorimotor disorder of uncomfortable leg sensations that appear at night and interfere with sleep, might be a cause for nighttime agitation in persons with AD. RLS is infrequently identified in persons with AD because traditional diagnosis is dependent on patients answering complex questions about their symptoms. With a validated observational tool for RLS diagnosis, the Behavioral Indicators Test-Restless Legs, we aim to diagnose RLS and determine the effect of an FDA-approved drug for RLS, gabapentin enacarbil (GEn), compared to placebo on nighttime agitation, sleep, antipsychotic medications, and the mechanism for these effects. We hypothesize that frequency of RLS behaviors will mediate the relationship between GEn and nighttime agitation. This study is an 8-week, double-blind, placebo-controlled, randomized pilot clinical trial, followed by an 8-week open-label trial, that is being conducted in long-term care (LTC) settings and private homes. The results of this study may shift, personalize, and improve standards of care for treatment of nighttime agitation; reduce aggression and other nighttime agitation behaviors; and improve sleep. Clinical Trials.gov Identifier: NCT03082755 (Date of registration 6 March 2017)
登录
查看更多内容
DOI：
10.1016/j.jalz.2011.03.005
发表时间：
2011-05
期刊：
Alzheimer's & dementia : the journal of the Alzheimer's Association
影响因子：
--
作者：
McKhann GM;Knopman DS;Chertkow H;Hyman BT;Jack CR Jr;Kawas CH;Klunk WE;Koroshetz WJ;Manly JJ;Mayeux R;Mohs RC;Morris JC;Rossor MN;Scheltens P;Carrillo MC;Thies B;Weintraub S;Phelps CH
通讯作者：
Phelps CH
影响因子：
6.9
作者：
ANTHONY, JC;LERESCHE, L;FOLSTEIN, MF
通讯作者：
FOLSTEIN, MF
影响因子：
2.9
作者：
Cundy, Kenneth C.;Sastry, Srikonda;Canafax, Daniel M.
通讯作者：
Canafax, Daniel M.
DOI：
10.1093/gerona/62.8.908
发表时间：
2007-08-01
影响因子：
5.1
作者：
Cohen-Mansfield, Jiska;Libin, Alexander;Marx, Marcia S.
通讯作者：
Marx, Marcia S.
影响因子：
1.6
作者：
Nitz, Jennifer C.;Hourigan, Susan R.;Brown, Annette
通讯作者：
Brown, Annette