Effect of a Dual Orexin Receptor Antagonist on CSF Alzheimer's Disease Biomarkers
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to see if the sleep aid, lemborexant, can decrease the amount of amyloid-beta and tau in the blood. Amyloid-beta and tau are proteins involved in the disease process leading to Alzheimer's disease.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: t
View:
• Male or female.
• Any race or ethnicity.
• Participants must be age ≥ 65 years and able to sign informed consent.
• Global Clinical Dementia Rating (CDR) 0.
• Willing and able to undergo study procedures.
Locations
United States
Missouri
Washington University in St. Louis, School of Medicine
RECRUITING
St Louis
Contact Information
Primary
Chloe Meehan, MA
cmeehan@wustl.edu
314-273-0878
Backup
Crirstina Toedebusch
toedebuschc@wustl.edu
314-747-0646
Time Frame
Start Date: 2024-03-11
Estimated Completion Date: 2029-03-11
Participants
Target number of participants: 201
Treatments
Experimental: Lemborexant 10 mg
Lemborexant is a capsule, taken by mouth once a night, approximately 30 minutes prior to bed for 6 months.
Experimental: Lemborexant 20 mg
Lemborexant is a capsule, taken by mouth once a night, approximately 30 minutes prior to bed for 6 months.
Placebo_comparator: Placebo
Placebo is in capsule form and contains an inactive substance. It is taken by mouth once a night, approximately 30 minutes prior to bed for 6 months.
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine
Collaborators: Eisai Inc., National Institute on Aging (NIA), National Institutes of Health (NIH)