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The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's

Study acronym: LUCINDA
StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary endpoints: details revised at 1 of 1 entry Show 5 more changesShow less
    • Trial completed
    • Final enrollment: 86 participants (planned 180)
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 3 of 6 entries
    • Publications: details revised at 4 of 4 entries
  2. Minor Primary and study completion dates: Jul 1, 2026 to Jul 25, 2026v19
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Aug 1, 2026 to Jul 1, 2026
    • Site details revised at 3 of 3 sites
    v18
  4. Minor Primary and study completion dates: May 2026 to Aug 1, 2026v17
  5. Minor Primary completion date: Dec 2025 to May 2026
    • Study completion date: Feb 2026 to May 2026
    • Site contacts updated at 3 of 3 sites
    • Publications: 3 to 4
    v16
Show 14 earlier versionsHide 14 earlier versions
  1. Notable Primary completion date: Feb 2025 to Dec 2025
    • Eligibility criteria shortened, about 24 words
    v15
  2. Minor Eligibility criteria shortened, about 37 wordsv14
  3. Minor Site details revised at 2 of 3 sitesv13
  4. Minor Site details revised at 1 of 3 sitesv12
  5. Minor Site contacts updated at 1 of 3 sitesv11
  6. Minor Re-verified, no change to tracked fieldsv10
  7. Minor Site contacts updated at 1 of 3 sitesv9
  8. Minor Start date changed from estimate of Dec 2020 to Nov 27, 2020v8 Show 4 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Site contacts updated at 1 of 3 sites
    • Collaborators: 1 to 2
    • Study description shortened, about 1 word
  9. Notable Start date: Sep 2020 to Dec 2020v7
  10. Notable Start date: Jun 2020 to Sep 2020v6
  11. Notable Start date: Feb 2020 to Jun 2020v5
  12. Notable Trial status: Not Yet Recruiting to Recruitingv4 Show 8 more changesShow less
    • Enrollment target: 50 to 180
    • Primary endpoint revised
    • Study sites: 1 to 3
    • Interventions: LUPRON DEPOT 22.5 mg (Drug), Placebo (Drug) to Eligard 22.5Mg Suspension for Injection (Drug), Placebo (Drug)
    • Eligibility criteria shortened, about 33 words
    • Secondary endpoints expanded, about 60 words
    • Study description expanded, about 170 words
    • Study title revised
  13. Notable Lead sponsor: NYU Langone Health to Weill Medical College of Cornell Universityv3 Show 6 more changesShow less
    • Primary completion date: Dec 2020 to Feb 2025
    • Start date: Dec 2018 to Feb 2020
    • Study completion date: Dec 2020 to Feb 2026
    • Eligibility criteria revised
    • Study site revised
    • Collaborators expanded, about 5 words
  14. Minor Re-verified, no change to tracked fieldsv2
  1. Minor 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 LUCINDA Trial is a three-site, phase II, randomized, double-blind, placebo-controlled study of leuprolide acetate (Eligard) in women with Mild Cognitive Impairment or Alzheimer's Disease taking a stable dose of a cholinesterase inhibitor medication like donepezil. Its objective is to assess the efficacy of a 48-week regimen of leuprolide (22.5 mg per 12 weeks) compared to placebo on cognitive function, global function and plasma and neuroimaging biomarkers.
Trial Details
NCT Number NCT03649724
Lead Sponsor Weill Medical College of Cornell University
Collaborators: National Institute on Aging (NIA), Tolmar Pharmaceuticals
Conditions
(from sponsor)
Alzheimer Disease, Mild Cognitive Impairment
Related terms Alzheimer Disease, Cognitive Dysfunction
Enrollment 86 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov