Trazodone for Sleep in Early Alzheimer's Disease
This study is looking at whether the medication trazodone (50mg) can improve sleep in people with Amnestic Mild Cognitive Impairment (aMCI), a type of memory problem that can be an early sign of Alzheimer's disease. Researchers want to see if trazodone helps you sleep longer overall and increases "Slow Wave Sleep" (SWS), which is a deep, restorative stage of sleep. You might be able to join if you are 55 or older, have mild memory problems, and also have sleep complaints. The study is currently unclear about its status, but plans to enroll 100 participants.
- Study design
- This is a randomized, placebo-controlled, double-blind crossover study, meaning participants will receive both trazodone and a placebo at different times, without knowing which they are taking. The study plans to enroll 100 participants.
- What's involved
- Participants will take either trazodone or a placebo for 4 weeks, followed by a 4-week break, and then switch to the other treatment for another 4 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Sleep duration and quality will be measured at the beginning and end of the study, up to 12 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Barry Greenberg, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
Who to contact
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What this trial measures
- Change in total sleep duration between the treatment armsBaseline and End of study, up to 12 weeks
Comparison of means of total sleep duration from baseline measured in minutes between trazodone and placebo arm.
- Change in Slow Wave Sleep (SWS) duration between the treatment armsBaseline and End of study, up to 12 weeks
Comparison of means of SWS from baseline measured in minutes between trazodone and placebo arm.
- Change in SWS intensity between the treatment armsBaseline and End of study, up to 12 weeks
Comparison of means of SWS intensity measured from baseline in volts squared between trazodone and placebo arm.
- Change in sleep onset latency between the treatment armsBaseline and End of study, up to 12 weeks
Comparison of means of sleep onset latency from baseline measured in minutes between trazodone and placebo arm.
- Change in sleep fragmentation between the treatment armsBaseline and End of study, up to 12 weeks
Comparison of means of sleep fragmentation from baseline measured in minutes between trazodone and placebo arm.
- Change in self reported sleep measure Pittsburgh Sleep Quality Index (PSQI) between treatment armsBaseline and End of study, up to 12 weeks
Comparison of means score for PSQI from baseline between trazodone and placebo arm. A higher score means a worse outcome.
- Change in self reported sleep measure Epworth Sleepiness Score (ESS) between treatment armsBaseline and End of study, up to 12 weeks
Comparison of means score for ESS from baseline between trazodone and placebo arm. A higher score means a worse outcome.