Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone — REST  

Sleep Disturbance Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dyssomnias
• Parasomnias
• Sleep Disturbance

• NCT number: NCT05282550
• Study type: Interventional
• Source: Johns Hopkins University
• Contact: Barry Greenberg, PhD
• Phone: 410-955-1696
• Email: bgreen45@jhmi.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: January 4, 2023
• Completion date: May 2028