Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone

RCT Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone (REST)

Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone (NCT05282550) is a Phase 2 interventional studying AMCI - Amnestic Mild Cognitive Impairment and Sleep Disturbance, sponsored by Johns Hopkins University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against AMCI - Amnestic Mild Cognitive Impairment and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused AMCI - Amnestic Mild Cognitive Impairment subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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) Who Should NOT Join This Trial: 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 willing to sign a consent form Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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) 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

Treatments Being Tested

DRUG

Trazodone

50mg of trazodone administered for 4 weeks.

DRUG

Placebo

Placebo administered for 4 weeks.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Johns Hopkins Hospital

Baltimore, Maryland, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05282550), the sponsor (Johns Hopkins University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05282550 clinical trial studying?

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). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05282550?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05282550?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05282550. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05282550. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.