Actively Recruiting

Phase 2
Age: 55Years +
All Genders
NCT05282550

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

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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

Age: 55Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21205

Actively Recruiting

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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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