Centre for Chronic Diseases of Ageing

What is the purpose of this research study?
When we sleep, the brain “cleans” itself of neurotoxins that have been building up during the day. These neurotoxin proteins in the brain (called beta amyloid and Tau) have been linked to the development of Alzheimer's disease and dementia. However, sleep disturbances, such as those associated with sleep disorders including insomnia, may hinder this essential process.

It has been suggested that treating sleep disorders, like insomnia, may improve the clearance of these neurotoxins. This study aims to further understand if Lemborexant affects brain health in the short term, including the levels of beta amyloid and Tau in the blood. Recruitment for the study will begin in early 2025.

What does participation in this research study involve?
If you agree to be involved in this study, you will be assessed for your suitability (screened), and if suitable, you will be asked to take two weeks of Lemborexant treatment and two weeks of a lookalike placebo. The placebo doesn't have any active ingredient, so it won't have any effect. You will receive the study drug just before each two-week treatment period begins. There will be a 2-4 week break between the Lemborexant and placebo treatments. The order of Lemborexant and placebo will be different for everyone. It's a "double-blind" study, so neither you, your doctor, nor the study staff will know which drug you're getting first. However, your doctor can find out if needed for your care. You will not be able to find out which drug you took until the entire clinical trial is complete. At the end of each two-week period of each study drug, you will be required to come into the labs at Woolcock for an overnight visit and testing.

Procedures
Study participation will involve 3 visits to the sleep centre at the Woolcock Institute of Medical Research, located at Macquarie University. These will include:

Visit 1: Screening and baseline assessment (approximately 2 hours)
Visit 2: Post study drug treatment 1 (overnight; approximately 5pm to 11am)
Visit 3: Post study drug treatment 2 (overnight; approximately 5pm to 11am)

Recruitment will start early 2025.

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