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A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults With Insomnia.

NCT06823752 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-10-03

No results posted yet for this study

Summary

The goal of this clinical trial is to explore the potential neuroprotective benefits of a dual orexin receptor antagonist (DORA) in adults with insomnia. The main questions it aims to answer are:

* Does the DORA reduce blood-based phosphorylated TAU181, in adults with insomnia, when compared to placebo
* Does the DORA reduce other blood-based biomarkers of neurodegeneration, including phosphorylated TAU217, amyloid beta 40:42 ratio, Neurofilament Light Chain (NFL) and Glial Fibrillary Acidic Protein (GFAP), when compared to placebo.

Participants will:

* Take 10mg Lemborexant nightly for two weeks
* Take a matching placebo nightly for two weeks
* Visit the research institute for a screening visit and for an overnight visit at the conclusion of each study drug treatment (3 visits in total).

Conditions

Interventions

DRUG

Lemborexant 10 MG

An orally ingested tablet containing 10mg Lemborexant taken before bedtime. The investigational product is manufactured under Good Manufacturing Practice and is compliant with the TGA Therapeutic Order #101 that stipulates quality control requirements for capsule and pill-based products used in Australia.

DRUG

Placebo

Placebo tablets will contain similar excipients without the active ingredient (Lemborexant) and manufactured under the same condition as the active. Placebo tablets, packs and instructions will be identical in every respect to enable the double-blind study design.

Sponsors & Collaborators

  • Woolcock Institute of Medical Research

    lead OTHER

Principal Investigators

  • Camilla Hoyos, MPH, PhD · Woolcock Institute of Medical Research

  • Brendon Yee, MBChB, FRACP, FCCP, PhD · Woolcock Institute of Medical Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-13
Primary Completion
2026-04-30
Completion
2026-04-30
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06823752 on ClinicalTrials.gov