By InvitationPhase 2

Stimulating Amyloid Clearance in Cerebral Amyloid Angiopathy

Netherlands60 participantsStarted 2025-03-27

Plain-language 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.

Who can participate

Age range30 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with D-CAA with a proven amyloid precursor protein (APP) mutation or a history of ≥1 lobar intracerebral haemorrhage (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, cerebral microbleeds) or non-haemorrhagic marker (white matter hyperintensities, enlarged perivascular spaces). * When presymptomatic, patients are aware that they have D-CAA * Probable sporadic CAA (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 microbleeds (MBs) and cortical superficial siderosis (cSS) present or a ratio of 10 times more lobar MBs than deep MBs without cSS. * Age ≥50 years old * ≤ 2 symptomatic ICH (occurrence of ICH at least \> 1 year ago) * Participants able to read and understand the patient information folder and who freely provide written informed consent Exclusion Criteria: * 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, during the intervention period. Co…

What they're measuring

Morning amyloid-beta 40 and 42 levels in cerebrospinal fluid

Timeframe: 3 months

Trial details

NCT IDNCT06421532

SponsorLeiden University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-27