Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone
Recruiting · NCT05282550 · Interventional (participants receive a specific treatment) · Lead sponsor: Johns Hopkins University
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboTrazodone
What this trial 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).
Who can take part
Age range
55 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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;
- Dementia;
- Cognitive complaints and deficits better explained by other medical/neurologic conditions;
- Delirium;
- 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 it is running
1 location listed across 1 US state.
- Johns Hopkins Hospital - Baltimore, Maryland, United States