DORA and LP in Alzheimer's Disease Biomarkers
ConditionAlzheimer Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Minnesota
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
History or reported symptoms suggestive of restless legs syndrome, narcolepsy, or parasomnia.
STOP-Bang score >6 for participants without PAP.
Untreated sleep apnea AHI>15
Poorly treated sleep apnea due to noncompliance or an AHI ≥ 10.
Trial design
Treatments tested in this trial
- Lemborexant 10 mg
- Lemborexant 20mg
- Placebo
Treatment groups
201 Participants
are divided into 3 treatment groupsLocations
1Washington University in St. Louis, School of Medicine63110, St LouisMissouri, United States
Sponsors and collaborators
University of Minnesota
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Eisai Inc.
Collaborator
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov