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Evaluation of Trazodone in OSA-MCI

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion date changed from estimate of May 30, 2025 to May 2, 2025 Completion date: Dec 31, 2025 to Feb 28, 2026v5 Show 1 more changeShow less
    • Completion date: Dec 31, 2025 to Feb 28, 2026
  2. Minor Trial status: Recruiting to Active, Not Recruiting Enrollment target: 124 to 134 · Primary completion date: Dec 31, 2024 to May 30, 2025 · Completion date: Dec 31, 2026 to Dec 31, 2025 · 1 morev4 Show 4 more changesShow less
    • Enrollment target: 124 to 134
    • Primary completion date: Dec 31, 2024 to May 30, 2025
    • Completion date: Dec 31, 2026 to Dec 31, 2025
    • Site details revised
  3. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of May 1, 2022 to May 10, 2022v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of May 1, 2022 to May 10, 2022
  4. Notable Start date: Feb 7, 2022 to May 1, 2022v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Alzheimer's disease (AD) is a progressive and multifactorial neurodegenerative disease. Before progressing to AD, individuals may experience mild cognitive impairment (MCI). While these individuals with MCI have an increased risk of progressing to AD, emerging studies reveal that obstructive sleep apnea (OSA) is a risk factor for both MCI an well as AD. Thus, it is worthwhile to identify clinical management or interventions that retard the conversion of subjects with comorbid MCI and OSA and AD. A randomized, double-blind, placebo-controlled study proposed herein aims to examine the effect of trazodone on reducing level sST2 and protein markers that are associated with neurodegeneration in the plasma of subjects with comorbid OSA and MCI. In this 1-year study, 124 study participants will undergo a series of neurocognitive assessments.
Trial Details
NCT Number NCT05209035
Lead Sponsor Chinese University of Hong Kong
Collaborators: Hong Kong University of Science and Technology
Conditions Mild Cognitive Impairment, Obstructive Sleep Apnea
Enrollment 134 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov