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Clear-Brain: stimulating amyloid clearance in cerebral amyloid angiopathy
EU CTIS ID: 2023-506128-10-00
What this study is testing
To assess whether treatment with non-invasive vagus nerve stimulation (nVNS), low-sodium oxybate (LXB) or both interventions will increase the clearance of amyloid-beta (aβ) from the cerebral blood vessels, compared to pre-treatment, in patients with cerebral amyloid angiopathy (CAA) by stimulating the glymphatic system.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with D-CAA with a proven APP mutation or a history of ≥1 lobar ICH and a positive family history for D-CAA in ≥1 first degree relative • Age ≥30 years old • ≤ 2 symptomatic ICH (occurrence of ICH at least > 1 year ago) or presence of ≥ 1 haemorrhagic marker (cortical superficial siderosis, cortical microbleeds) or non-haemorrhagic marker (white matter hyperintensities, microinfarcts, enlarged perivascular spaces, lobar lacunes). • When presymptomatic, patients are aware that they have D-CAA
- Probable sCAA according to the Modified Boston criteria 2.0 • Age ≥50 years old • ≤ 2 symptomatic ICH (occurrence of ICH at least > 1 year ago)
- Provisional CAA when the criteria for probable sCAA are not met due to presence of deep haemorrhagic lesions but there are mostly lobar MB and cSS present or a ratio of 10 times more lobar MB than deep MB without cSS. • Age ≥50 years old • ≤ 2 symptomatic ICH (occurrence of ICH at least > 1 year ago)
- Written informed consent
You likely can't join if
- Modified Rankin Score ≥ 4
- A life expectancy of less than six months
- Pregnancy/breast feeding
- Contraindications for lumbar puncture
- Unwillingness to refrain from consuming ≤ 1 alcohol unit per day and not later than 8 pm.
- Contraindications for LXB and nVNS
See the full eligibility criteria
- Patients with D-CAA with a proven APP mutation or a history of ≥1 lobar ICH and a positive family history for D-CAA in ≥1 first degree relative • Age ≥30 years old • ≤ 2 symptomatic ICH (occurrence of ICH at least > 1 year ago) or presence of ≥ 1 haemorrhagic marker (cortical superficial siderosis, cortical microbleeds) or non-haemorrhagic marker (white matter hyperintensities, microinfarcts, enlarged perivascular spaces, lobar lacunes). • When presymptomatic, patients are aware that they have D-CAA
- Probable sCAA according to the Modified Boston criteria 2.0 • Age ≥50 years old • ≤ 2 symptomatic ICH (occurrence of ICH at least > 1 year ago)
- Provisional CAA when the criteria for probable sCAA are not met due to presence of deep haemorrhagic lesions but there are mostly lobar MB and cSS present or a ratio of 10 times more lobar MB than deep MB without cSS. • Age ≥50 years old • ≤ 2 symptomatic ICH (occurrence of ICH at least > 1 year ago)
- Written informed consent
- Modified Rankin Score ≥ 4
- A life expectancy of less than six months
- Pregnancy/breast feeding
- Contraindications for lumbar puncture
- Unwillingness to refrain from consuming ≤ 1 alcohol unit per day and not later than 8 pm.
- Contraindications for LXB and nVNS
- Contraindications for MRI 7T
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.