Sleep drug trazodone tested to boost memory in Alzheimer's
NCT ID NCT05282550
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether trazodone, a sleep medication, can improve sleep and memory in people with early Alzheimer's and sleep problems. About 100 participants will receive either trazodone or a placebo for 4 weeks. Researchers will measure changes in sleep quality and memory performance.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- trazodone
- What this could lead to
- If it works, this could point toward a simple way to improve sleep and possibly slow memory decline in early Alzheimer's.
- What could go wrong
- This is a small, early-phase trial. Trazodone may not improve sleep or memory significantly, and results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2023
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Mild Cognitive Impairment (MCI) as defined by Albert et al.2 including subjective memory complaint and/or objective evidence of memory problems; 2. Clinical Dementia Rating (CDR) of 0.5 with a Memory Box score of \>=0.5; 3. Evidence of sleep complaints with Pittsburgh Sleep Quality Index score of \>5 (a well-validated cutoff observed in \>40% of older persons); 4. Memory performance \> 1.5 Standard Deviation (SD) below age-and education-matched control subjects on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) List Recall; 5. Visual and auditory acuity adequate for neuropsychological testing; 6. Good general health with no disease expected to interfere with the study; 7. Able to have Magnetic Resonance Imaging (MRI) scan; 8. Availability of knowledgeable informant (KI) 9. Buschke Selective Reminding Test or more standard deviations below age-education norms Exclusion Criteria: 1. Less than 55 years of age to reduce likelihood of including individuals with frontotemporal dementia or non-dementia MCI; 2. Too frail or medically unstable to undergo study procedures; 3. 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; 4. Dementia; 5. Cognitive complaints and deficits better explained by other medical/neurologic conditions; 6. Delirium; 7. Allergic to trazodone; 8. Taking sleep medications including trazodone; 9. Current substance abuse; 10. Current major depressive, manic, or acute psychotic episode; 11. Prior diagnosis of significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol or represent alternate primary cause of memory problems beyond Alzheimer's Disease (AD) pathology: 12. Lack of available KI; 13. Prior diagnosis of Q wave T wave Corrected for heart rate (QTc) \> 470 msec (females) or \> 450 msec (males); 14. Inability to provide informed consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Johns Hopkins Hospital
RECRUITINGBaltimore, Maryland, 21205, United States
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