Massachusetts General Hospital
The DEXTER study is a cross-over, double-blind, placebo-controlled pilot research study led by Dr. Peng Li. The goal of this project is to evaluate the safety, feasibility, and biological effects of a single dose of sublingual (under-the-tongue) dexmedetomidine (SL Dex) in older adults. Specifically, researchers want to see how this medication affects sleep patterns, internal 24-hour circadian rhythms, and the daily cycles of certain neurological proteins (specifically plasma p-tau217) associated with brain aging.
Circadian rhythms are fundamental regulators of human physiology, coordinating sleep-wake timing, neural activity, metabolic processes, and hormonal signaling across the 24-hour day. These endogenous rhythms are coordinated by the suprachiasmatic nucleus (SCN), the central circadian pacemaker in the hypothalamus that integrates environmental cues such as light to synchronize peripheral and central biological processes. In older adults, circadian rhythms often degrade, exhibiting reduced robustness and impaired alignment with behavioral cycles. Such alterations are closely linked to disrupted s…
Inclusion Criteria: * Age 65 years or older * Able to provide informed consent * Willing and able to comply with all study procedures, including in-laboratory and ambulatory monitoring * Able to provide informed consent using an IRB-approved translated consent document (when available) and complete study procedures with translated materials and/or qualified interpreter services, if needed- Stable residence and sleep schedule sufficient to complete study monitoring periods * Able to safely discontinue or adjust medications that may interfere with study procedures or outcomes, as determined by…
Participants receive a single 120 mcg dose of sublingual dexmedetomidine (IGALMI®) administered approximately 15-20 minutes before the scheduled sleep opportunity during the in-laboratory protocol.
Participants receive a matched placebo sublingual film identical in appearance, packaging, and administration method to the active dexmedetomidine formulation but containing no active medication.
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