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 groupsSponsors 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