NCT05282550RecruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 8 Mar 2022
- Start date
- 2 Feb 2023
- Primary completion date
- 30 Jul 2027
- Lead sponsor
- Johns Hopkins University
- Diseases
- Alzheimer disease
- NCT number
- NCT05282550
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 2 Feb 2023 to the primary completion date, 30 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Taking sleep medications including trazodone;
- 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:
Other illness
- Dementia;
- Cognitive complaints and deficits better explained by other medical/neurologic conditions;
- Allergic to trazodone;
Lab values
- Prior diagnosis of Q wave T wave Corrected for heart rate (QTc) \> 470 msec (females) or \> 450 msec (males);
Age
- Less than 55 years of age to reduce likelihood of including individuals with frontotemporal dementia or non-dementia MCI;
Other
- Too frail or medically unstable to undergo study procedures;
- Delirium;
- Current substance abuse;
- Current major depressive, manic, or acute psychotic episode;
- Lack of available KI;
- Inability to provide informed consent
Who the study is looking for
- Mild Cognitive Impairment (MCI) as defined by Albert et al.2 including subjective memory complaint and/or objective evidence of memory problems;
- Clinical Dementia Rating (CDR) of 0.5 with a Memory Box score of \>=0.5;
- Evidence of sleep complaints with Pittsburgh Sleep Quality Index score of \>5 (a well-validated cutoff observed in \>40% of older persons);
- 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;
- Visual and auditory acuity adequate for neuropsychological testing;
- Good general health with no disease expected to interfere with the study;
- Able to have Magnetic Resonance Imaging (MRI) scan;
- Availability of knowledgeable informant (KI)
- Buschke Selective Reminding Test or more standard deviations below age-education norms
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.