NCT05282550 · Phase 2 · RECRUITING
Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone
This trial is testing whether low-dose trazodone, a medication already used for sleep, can improve sleep quality and memory in people with amnestic mild cognitive impairment who also have sleep problems. Researchers will measure total sleep time, slow-wave sleep, and hippocampal memory function. It is a Phase 2 trial, meaning researchers are still gathering evidence on whether it works and is safe — it is not proven or approved for this purpose.
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) 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-09-18