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DORA and LP in Alzheimer's Disease Biomarkers

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Sponsor changed: Washington University School of Medicine to University of Minnesotav13
  2. Primary and study completion dates: Mar 11, 2029 to Mar 31, 2030v12
  3. Eligibility criteria shortened, about 3 wordsv11
  4. Site contact updated
    • Eligibility criteria shortened, about 1 word
    v10
  5. Primary endpoint revisedv9 Show 4 more changesShow less
    • Secondary endpoints revised (6)
    • Site contact updated
    • Eligibility criteria expanded, about 1 word
    • Study description shortened, about 1 word
Show 7 earlier versionsHide 7 earlier versions
  1. Collaborators: 2 to 3v8
  2. Secondary endpoints revised (6)
    • Collaborators expanded, about 7 words
    v7
  3. Eligibility criteria expanded, about 9 wordsv6
  4. 2 versions Re-verified since Mar 25, 2024, no change to tracked fieldsv4-v5
  5. Primary completion date: Feb 1, 2029 to Mar 11, 2029
    • Study completion date: Feb 1, 2031 to Mar 11, 2029
    v3
  6. Start date: Mar 1, 2024 to Mar 11, 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06274528
Lead Sponsor University of Minnesota
Collaborators: National Institutes of Health (NIH), Eisai Inc., National Institute on Aging (NIA)
Conditions
(from sponsor)		 Alzheimer Disease
Related terms Alzheimer Disease
Enrollment 201 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov