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Stimulating Amyloid Clearance in Cerebral Amyloid Angiopathy

Study acronym: Clear-Brain
StatusEnrolling by Invitation
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoint revised Secondary endpoints: 3 to 21v3 Show 1 more changeShow less
    • Secondary endpoints: 3 to 21

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Enrolling by Invitation Primary and study completion dates: Aug 1, 2026 to Sep 27, 2027 · Start date changed from estimate of Jun 1, 2024 to Mar 27, 2025 · Study sites: 0 to 1v2 Show 3 more changesShow less
    • Primary and study completion dates: Aug 1, 2026 to Sep 27, 2027
    • Start date changed from estimate of Jun 1, 2024 to Mar 27, 2025
    • Study sites: 0 to 1
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A pre-post study will be conducted to assess whether treatment with LXB, nVNS or a combination of both interventions can enhance the clearance of Aβ in patients with CAA. A total of 60 subjects, 30 with sCAA and 30 with D-CAA, will be randomly assigned to receive LXB, or both interventions. The primary outcome measure will be the morning levels of Aβ40 and Aβ42 in cerebrospinal fluid (CSF) before and after the intervention. The investigators will assess disease progression with (non-)haemorrhagic imaging markers on 7-Tesla Magnetic Resonance Imaging (7-T MRI) as a secondary outcome. Additionally, the activity of the glymphatic system by means of fluid dynamics will be assessed using 7-T MRI.
Trial Details
NCT Number NCT06421532
Lead Sponsor Leiden University Medical Center
Collaborators: The Dutch Brain Foundation
Conditions Cerebral Amyloid Angiopathy
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov