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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 55 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 4 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The investigators will randomize 100 subjects and administer trazodone and placebo for 4 weeks each with a 4-week washout period in between."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how trazodone affects sleep, memory, and activity in a brain area used for memory. It is for adults age 55 or older with mild memory problems and sleep complaints, but not dementia. Researchers think trazodone may increase total sleep time and time spent in deep sleep.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have mild cognitive impairment, meaning mild memory problems that you notice or that tests show.
- Have a Clinical Dementia Rating of 0.5 and a memory score of at least 0.5 on that rating.
- Have sleep complaints and a Pittsburgh Sleep Quality Index score above 5.
- Score more than 1.5 standard deviations below people of similar age and education on the RBANS word recall test. This means a score well below average.
- Meet a Buschke memory test requirement. The listing does not clearly state the required score.
- Have good enough sight and hearing to take memory and thinking tests.
- Be in good general health, with no illness that would interfere with the study, and be able to have an MRI scan.
- Have someone who knows you well and can give information about you.
Who can't join
- Are younger than 55, too frail, or too medically unstable for study procedures.
- Have a past diagnosis of obstructive sleep apnea, which causes pauses in breathing during sleep, or more than 15 breathing pauses or reductions per hour on the study's home sleep test.
- Have dementia, sudden confusion called delirium, or memory problems better explained by another medical or brain condition.
- Are allergic to trazodone or take sleep medicines, including trazodone.
- Currently misuse alcohol or drugs, or have a major depression episode, mania, or an acute psychotic episode. Mania means unusually high energy or mood; psychosis can involve losing touch with reality.
- Have a serious or unstable illness that could make study participation difficult or be another main cause of memory problems.
- Have a past diagnosis of a long QTc, a measure of the heart's electrical timing: above 470 milliseconds for females or 450 for males.
- Do not have someone who knows you well to give information, or cannot give informed consent to join.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (1)
MD
- Johns Hopkins Hospital · Baltimore, MD 21205Barry Greenberg, PhD · Study contact · 410-955-1696 · bgreen45@jhmi.eduPaul Rosenberg, MD · Study contact · 410-550-9883 · prosenb9@jhmi.eduBarry Greenberg, PhD · Principal investigatorMore trials in Baltimore