RCT Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone (REST)

Johns Hopkins University2 个研究点分布在 1 个国家目标入组 100 人开始时间: 2023年2月2日最近更新: 2026年6月17日

适应症

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方: Johns Hopkins University
入组人数: 100
试验地点: 2
主要终点: Change in Slow Wave Sleep (SWS) duration between the treatment arms

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To investigate the effect of trazodone on sleep, hippocampal-dependent memory and hippocampal excitability. The investigators hypothesize that trazodone will improve total sleep time and proportion of time in Slow Wave Sleep (SWS).

详细描述

The REST trial is a randomized, placebo-controlled, double-blind crossover study of trazodone (50 mg at bedtime) in participants with Amnestic Mild Cognitive impairment (aMCI) and sleep complaints. The investigators will randomize 100 subjects and administer trazodone and placebo for 4 weeks each with a 4-week washout period in between. A 4-week washout period is more than sufficient due to trazodone's elimination half-life of 10-12 hours. The crossover design will facilitate recruitment and enable the use of the subjects as a control without requiring a parallel placebo arm.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Study drug will be compounded by the Investigational Drug Service (IDS) at Johns Hopkins Bayview Medical Center. The IDS will prepare blind medication using opaque capsules and randomly assign eligible participants to treatment order (ie, starting with trazodone vs. placebo treatment).

入排标准

年龄范围: 55 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Mild Cognitive Impairment (MCI) as defined by Albert et al.2 including subjective memory complaint and/or objective evidence of memory problems;
•Clinical Dementia Rating (CDR) of 0.5 with a Memory Box score of >=0.5;
•Evidence of sleep complaints with Pittsburgh Sleep Quality Index score of >5 (a well-validated cutoff observed in >40% of older persons);
•Memory performance > 1.5 Standard Deviation (SD) below age-and education-matched control subjects on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) List Recall;
•Visual and auditory acuity adequate for neuropsychological testing;
•Good general health with no disease expected to interfere with the study;
•Able to have Magnetic Resonance Imaging (MRI) scan;
•Availability of knowledgeable informant (KI)
•Buschke Selective Reminding Test or more standard deviations below age-education norms

排除标准

•Less than 55 years of age to reduce likelihood of including individuals with frontotemporal dementia or non-dementia MCI;
•Too frail or medically unstable to undergo study procedures;
•Prior diagnosis of Obstructive Sleep Apnea (OSA) or evidence of moderate-to-severe OSA on baseline Home Sleep Test (HST) as evidenced by an apnea/hypopnea index of >15;
•Cognitive complaints and deficits better explained by other medical/neurologic conditions;
•Allergic to trazodone;
•Taking sleep medications including trazodone;
•Current substance abuse;
•Current major depressive, manic, or acute psychotic episode;
•Prior diagnosis of significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol or represent alternate primary cause of memory problems beyond Alzheimer's Disease (AD) pathology:
•Lack of available KI;
•Prior diagnosis of Q wave T wave Corrected for heart rate (QTc) > 470 msec (females) or > 450 msec (males);
•Inability to provide informed consent

研究组 & 干预措施

Placebo First

Placebo Comparator

Placebo and then Trazodone (50 mg at bedtime) after a 4-week washout period.

干预措施: Placebo (Drug)

Trazodone First

Active Comparator

Trazodone (50 mg at bedtime) and then placebo after a 4-week washout period.