Clinical Trial

Stimulating Amyloid Clearance in Cerebral Amyloid Angiopathy

Study acronym: Clear-Brain
Enrolling by Invitation Phase 2
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-05-14; most recent amendment 2026-02-19.
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-09-16
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 2025-03-27
Primary Completion 2027-09-27 (estimated)
Study Completion 2027-09-27 (estimated)
Updated on ClinicalTrials.gov 2026-02-24