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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Lemborexant 10 mg
Drug
Within FDA approved dose 10 mg; capsule; QD, 6 month duration
Lemborexant 20mg
Drug
20 mg; capsule; QD; 6 month duration
Placebo
Drug
0 mg; capsule; QD; 6 month duration

Treatment groups

201 Participants

are divided into 3 treatment groups

Group A: Lemborexant 10 mgExperimental treatment 1 intervention

Group B: Lemborexant 20 mgExperimental treatment 1 intervention

Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Changes plasma pT181/T181 ratio of lemborexant 10 and 20 mg compared to Placebo

plasma collection

Time frame

6 months

Secondary outcomes

Number of participants with treatment-related adverse events

Adverse events

Time frame

6 months

Measure the blood concentration of lemborexant 10 mg and 20 mg and determine the dose-response relationship with CSF pT181/T181

Blood collection

Time frame

6 months

Measure changes on blood plasma amyloid-beta isoforms (Aβ38, Aβ40, Aβ42, Aβ42/Aβ40)

Blood collection

Time frame

6 months

Measure changes of CSF amyloid beta isoforms (Aβ38, Aβ40, Aβ42,Aβ42/Aβ40 )

CSF collection

Time frame

6 months

Other outcomes

Measure changes of cerebrospinal TREM2 (exploratory)

CSF

Time frame

6 months

Measure changes of cerebrospinal NPTX2 (exploratory)

CSF

Time frame

6 months

Measure changes of cerebrospinal NfL (exploratory)

CSF

Time frame

6 months

Measure changes of blood plasma NfL (exploratory)

Blood

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Eisai Inc.

Collaborator

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov

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