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Antidepressant
Trazodone for Early Alzheimer's Disease (REST Trial)
Verified 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
Do you have someone who could accompany you to the study visits?
Are you older than 55?
Must not have
You have been diagnosed with Sleep Apnea
Are you currently taking any sleep medications that you're not willing or able to stop for two weeks prior to the study?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and end of study, up to 12 weeks
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and end of study, up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and end of study, up to 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
Change in hippocampal activation on Function Magnetic Resonance Imaging (fMRI) measures during memory functioning between treatment arms
Change in memory performance between treatment arms
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
2,339 Previous Clinical Trials
14,881,573 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,804 Previous Clinical Trials
28,194,799 Total Patients Enrolled
Barry Greenberg, PhDPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can see and hear well enough for brain function tests.
Research Study Groups:
This trial has the following groups:- Group 1: Trazodone First
- Group 2: Placebo First
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Mild Cognitive Impairment Patient Testimony for trial: Trial Name: NCT05282550 — Phase 2