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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Daily before bedtime for 3 months
Twice daily for 3 months
Leiden University Medical Center (LUMC)
Leiden, Netherlands
Amyloid-beta 40 and 42 in cerebrospinal fluid
Difference between before and after intervention
Time frame: 3 months
Disease progression with (non-)haemorrhagic imaging markers on 7-T MRI
Intracerebral haemorrhages, cerebral microbleeds, cortical superficial siderosis, white matter hyperintensities, perivascular spaces, cerebrovascular reactivity
Time frame: 2x 3 months
Other liquid biomarkers
Levels of amyloid-beta 38, 43, t-tau and p-tau181 in CSF and levels of amyloid-beta 40 and 42 in serum.
Time frame: 3 months
Activity of the glymphatic system by means of fluid dynamics on 7-T MRI
CSF motion
Time frame: 2x 3 months
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