Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone (NCT05282550) | Clinical Trial Compass
RecruitingPhase 2
Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone
United States100 participantsStarted 2023-02-02
Plain-language summary
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).
Who can participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Exclusion criteria
. Less than 55 years of age to reduce likelihood of including individuals with frontotemporal dementia or non-dementia MCI;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in total sleep duration between the treatment arms
Timeframe: Baseline and End of study, up to 12 weeks
2
Change in Slow Wave Sleep (SWS) duration between the treatment arms
Timeframe: Baseline and End of study, up to 12 weeks
3
Change in SWS intensity between the treatment arms
Timeframe: Baseline and End of study, up to 12 weeks
4
Change in sleep onset latency between the treatment arms
Timeframe: Baseline and End of study, up to 12 weeks
5
Change in sleep fragmentation between the treatment arms
Timeframe: Baseline and End of study, up to 12 weeks
6
Change in self reported sleep measure Pittsburgh Sleep Quality Index (PSQI) between treatment arms
Timeframe: Baseline and End of study, up to 12 weeks
7
Change in self reported sleep measure Epworth Sleepiness Score (ESS) between treatment arms
. 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;
. Dementia;
. Cognitive complaints and deficits better explained by other medical/neurologic conditions;
. Delirium;
. Allergic to trazodone;
. Taking sleep medications including trazodone;
Timeframe: Baseline and End of study, up to 12 weeks