NCT05282550

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• AMCI - Amnestic Mild Cognitive Impairment
• Sleep Disturbance

Interventions

Type	Name	Description
DRUG	Trazodone	50mg of trazodone administered for 4 weeks.
DRUG	Placebo	Placebo administered for 4 weeks.

Timeline

• Start date: 2023-02-02
• Primary completion: 2027-07-30
• Completion: 2028-06-30
• First posted: 2022-03-16
• Last updated: 2025-09-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study