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Antidepressant

Trazodone for Early Alzheimer's Disease (REST Trial)

Phase 2
Recruiting
Led By Barry Greenberg, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Evidence of sleep complaints with Pittsburgh Sleep Quality Index score of >5
Able to have Magnetic Resonance Imaging (MRI) scan
Must not have
Less than 55 years of age
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and end of study, up to 12 weeks
Awards & highlights

REST Trial Summary

This trial will investigate whether trazodone can improve sleep and memory by looking at hippocampal excitability.

Who is the study for?
This trial is for adults with mild cognitive impairment, memory problems, and sleep complaints. They must be in good health, able to undergo MRI scans, and have a caregiver who can provide information. Excluded are those under 55, with severe sleep apnea or dementia, allergic to trazodone, using sleep meds or substances, having major psychiatric episodes or unstable medical conditions.Check my eligibility
What is being tested?
The study tests if Trazodone improves sleep and memory in early Alzheimer's by increasing total sleep time and Slow Wave Sleep (SWS). Participants will either receive Trazodone or a placebo without knowing which one they're taking.See study design
What are the potential side effects?
Trazodone may cause drowsiness, dizziness upon standing up too fast (orthostatic hypotension), dry mouth, blurred vision or confusion. It might also affect heart rhythm (QTc prolongation) especially at higher doses.

REST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have trouble sleeping, as shown by my sleep test score.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am under 55 years old.
Select...
I have been diagnosed with moderate-to-severe sleep apnea.

REST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and end of study, up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and end of study, up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in SWS intensity between the treatment arms
Change in Slow Wave Sleep (SWS) duration between the treatment arms
Change in self reported sleep measure Epworth Sleepiness Score (ESS) between treatment arms
+4 more
Secondary outcome measures
Change in hippocampal activation on Function Magnetic Resonance Imaging (fMRI) measures during memory functioning between treatment arms
Change in memory performance between treatment arms

REST Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Trazodone FirstActive Control2 Interventions
Trazodone (50 mg at bedtime) and then placebo after a 4-week washout period.
Group II: Placebo FirstPlacebo Group2 Interventions
Placebo and then Trazodone (50 mg at bedtime) after a 4-week washout period.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,263 Previous Clinical Trials
14,823,065 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,825 Total Patients Enrolled
Barry Greenberg, PhDPrincipal InvestigatorJohns Hopkins University

Media Library

Trazodone (Antidepressant) Clinical Trial Eligibility Overview. Trial Name: NCT05282550 — Phase 2
Sleep Disorder Research Study Groups: Trazodone First, Placebo First
Sleep Disorder Clinical Trial 2023: Trazodone Highlights & Side Effects. Trial Name: NCT05282550 — Phase 2
Trazodone (Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05282550 — Phase 2
Sleep Disorder Patient Testimony for trial: Trial Name: NCT05282550 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study still accepting new participants?

"This medical study is currently looking for individuals to participate. The trial was initially published on 10th January, 2023 and its details were last modified on 22nd November of the same year."

Answered by AI

What is the cap on enrollees for this medical experiment?

"Affirmative, the information provided by clinicaltrials.gov affirms that recruiting is underway for this medical trial. The initial post was published on January 10th 2023 and recently updated on November 22nd 2022. A total of 100 participants must be enrolled at a single location to complete the study."

Answered by AI

Has the FDA officially sanctioned Trazodone as a medication?

"Our safety evaluation of Trazodone First resulted in a score of 2 as clinical data points to its safety, yet efficacy remains unproven."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Depression is creeping up.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone
2023. "Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05282550.
All > Sleep Disorder
~67 spots leftby Mar 2027
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