Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421532
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-08
Brief Title:
Stimulating Amyloid Clearance in Cerebral Amyloid Angiopathy
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Clear-Brain
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None