Dexmedetomidine Trial for Effects on Rhythms, Sleep Architecture, and Biomarker Dynamics in Older Adults

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07800910
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Circadian Rhythm
  • Sleep

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Dexmedetomidine sublingual film — DRUG
    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.
  • Placebo Sublingual Film — DRUG
    Participants receive a matched placebo sublingual film identical in appearance, packaging, and administration method to the active dexmedetomidine formulation but containing no active medication.

Study Details

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.

Key Dates

First listed
Sep 2, 2026
Start date
Sep 1, 2026
Status verified
May 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Sublingual Dexmedetomidine First
    Participants receive a single 120 mcg dose of sublingual dexmedetomidine (IGALMI®) during the first in-laboratory study period and matched placebo during the second study period after a washout interval of at least 3 weeks. The study evaluates effects on sleep architecture, circadian physiology, and plasma tau biomarker dynamics under controlled laboratory conditions.
  • Placebo Comparator: Placebo First
    Participants receive matched placebo during the first in-laboratory study period and a single 120 mcg dose of sublingual dexmedetomidine (IGALMI®) during the second study period after a washout interval of at least 3 weeks. The study evaluates effects on sleep architecture, circadian physiology, and plasma tau biomarker dynamics under controlled laboratory conditions.

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: From first study intervention through completion of the 10-day ambulatory follow-up following the second study period ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Peng Li, PhD
[email protected]
617-643-9514
Massachusetts General HospitalBostonMassachusetts02129-

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By research site
Brigham and Women's Hospital· Boston, MAMassachusetts General Hospital· Boston, MA

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