Actively Recruiting
Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone
Led by Johns Hopkins University · Updated on 2025-09-18
100
Participants Needed
1
Research Sites
282 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have mild cognitive impairment with memory complaints or evidence of memory problems
- Clinical Dementia Rating of 0.5 with Memory Box score of 0.5 or higher
- Sleep complaints with Pittsburgh Sleep Quality Index score above 5
- Memory performance more than 1.5 standard deviations below age and education matched controls on RBANS List Recall
- Adequate vision and hearing for neuropsychological tests
- Good general health without diseases that interfere with the study
- Able to have an MRI scan
- Have a knowledgeable informant available
You will not qualify if you...
- Younger than 55 years old
- Too frail or medically unstable for study procedures
- Diagnosis of obstructive sleep apnea or moderate-to-severe sleep apnea on baseline sleep test
- Dementia diagnosis
- Memory problems explained by other medical or neurological conditions
- Delirium
- Allergy to trazodone
- Taking sleep medications including trazodone
- Current substance abuse
- Current major depressive, manic, or psychotic episode
- Significant systemic illness or unstable medical condition affecting compliance or memory
- No knowledgeable informant available
- Prior abnormal heart rhythm (QTc prolongation)
- Unable to provide informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
B
Barry Greenberg, PhD
CONTACT
P
Paul Rosenberg, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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