NCT06421532

Stimulating Amyloid Clearance in Cerebral Amyloid Angiopathy

A Partial Randomised Clinical Trial Investigating Stimulation of the Glymphatic System by Either Deepening Sleep With Lower-sodium Oxybate or Inhibiting Cortical Spreading Depressions With Non-invasive Vagus Nerve Stimulation, or Both, in Patients With Cerebral Amyloid Angiopathy (CAA)

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Amyloid Angiopathy

Interventions

Type	Name	Description
DRUG	XYWAV	Daily before bedtime for 3 months
DEVICE	gammaCore Sapphire	Twice daily for 3 months

Timeline

• Start date: 2025-03-27
• Primary completion: 2027-09-27
• Completion: 2027-09-27
• First posted: 2024-05-20
• Last updated: 2026-02-24

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study