Targeting Cognition in Early Alzheimer’s Disease by Improving Sleep with Trazodone (REST) is a phase 2 clinical trial examining trazodone’s effect on sleep in patients with amnestic mild cognitive impairment (aMCI). Secondary outcomes include assessments of the treatment’s effect on cognition, memory, biomarkers of Alzheimer’s disease (AD) pathology, and hippocampal function and excitability (brain structure involved with memory and learning). Healthy sleep is crucial for hippocampal-dependent memory consolidation. Studies have shown that improving sleep can positively alter the course of AD.
Trazodone is a generic antidepressant commonly used off-label to treat sleep disturbance. Changes in the patient’s sleep will be measured by sleep studies (polysomnography), a sensor worn on the patient’s wrist (actigraphy), and the patient’s sleep diary. Other assessments will be made using task-related functional magnetic resonance imaging (MRI).
REST is a single-site, randomized, placebo-controlled, double-blind crossover trial. BIOS CTCC will serve as the DCC. This National Institute on Aging (NIA)-funded trial plans to enroll 100 participants.
ClinicalTrials.gov Identifier: NCT05282550