DORA and LP in Alzheimer's Disease Biomarkers

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06274528
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Mar 11, 2024
Status verified
Apr 2026
Primary completion
Mar 31, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
201 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Changes plasma pT181/T181 ratio of lemborexant 10 and 20 mg compared to Placebo [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University in St. Louis, School of MedicineSt LouisMissouri63110
Cristina Toedebusch, BS
[email protected]
314-747-0646
Chloe Meehan, BS, MA
[email protected]
314-273-0878
Brendan P. Lucey, M.D. (PRINCIPAL_INVESTIGATOR)
J. Philip Miller, Ph.D. (SUB_INVESTIGATOR)
Jason Hassenstab, Ph.D. (SUB_INVESTIGATOR)
David Carr, M.D. (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Washington University in St. Louis, School of Medicine· St Louis, MO

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