NCT05282550 · Johns Hopkins University
Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone
(REST)
What this study 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).
View original scientific description
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).
Interventions
DRUG
Trazodone
50mg of trazodone administered for 4 weeks.
DRUG
Placebo
Placebo administered for 4 weeks.
Primary outcome measures
Change in total sleep duration between the treatment arms
Time frame: Baseline and End of study, up to 12 weeks
Comparison of means of total sleep duration from baseline measured in minutes between trazodone and placebo arm.
Change in Slow Wave Sleep (SWS) duration between the treatment arms
Time frame: Baseline and End of study, up to 12 weeks
Comparison of means of SWS from baseline measured in minutes between trazodone and placebo arm.
Change in SWS intensity between the treatment arms
Time frame: Baseline and End of study, up to 12 weeks
Comparison of means of SWS intensity measured from baseline in volts squared between trazodone and placebo arm.
Change in sleep onset latency between the treatment arms
Time frame: Baseline and End of study, up to 12 weeks
Comparison of means of sleep onset latency from baseline measured in minutes between trazodone and placebo arm.
Change in sleep fragmentation between the treatment arms
Time frame: Baseline and End of study, up to 12 weeks
Comparison of means of sleep fragmentation from baseline measured in minutes between trazodone and placebo arm.
Change in self reported sleep measure Pittsburgh Sleep Quality Index (PSQI) between treatment arms
Time frame: Baseline and End of study, up to 12 weeks
Comparison of means score for PSQI from baseline between trazodone and placebo arm. A higher score means a worse outcome.
Change in self reported sleep measure Epworth Sleepiness Score (ESS) between treatment arms
Time frame: Baseline and End of study, up to 12 weeks
Comparison of means score for ESS from baseline between trazodone and placebo arm. A higher score means a worse outcome.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Less than 55 years of age to reduce likelihood of including individuals with frontotemporal dementia or non-dementia MCI;
- Too frail or medically unstable to undergo study procedures;
- 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;
- Cognitive complaints and deficits better explained by other medical/neurologic conditions;
- Allergic to trazodone;
- Taking sleep medications including trazodone;
- Current substance abuse;
- Current major depressive, manic, or acute psychotic episode;
- 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:
- Lack of available KI;
- Prior diagnosis of Q wave T wave Corrected for heart rate (QTc) \> 470 msec (females) or \> 450 msec (males);
- Inability to provide informed consent
Where
- Baltimore, Maryland
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2026 · Source of record for eligibility and locations