Peri-lymphatic Healing Approach for Intracranial Drainage in Refractory Amyloid-angiopathy

INTERVENTION: Group 1: Intervention group (CSLUS): Supermicrosurgical lymphovenous anastomosis in side‐to‐end technique between the deep cervical lymphatic vessels and adjacent veins to improve lymphatic drainage from the brain, performed by an experienced plastic surgical team, in addition to unchanged standard therapy. Postoperative inpatient monitoring for approx. 48 hours, followed by outpatient care with clinical and ultrasound examinations of the cervical region. Study visits with cognitive testing (MMSE, MoCA, DemTect), quality‐of‐life assessment (SF‐36) and blood and cerebrospinal fluid parameters at 1 week, 4 weeks, 3, 6 and 12 months. Group 2: Control group: Continuation of standard therapy (including existing medication, strict blood pressure control and avoidance of risk‐increasing anticoagulant medication) without surgical intervention. Study visits and assessments (cognitive testing with MMSE, MoCA and DemTect, quality of life using the SF‐36, blood and cerebrospinal fluid parameters) take place at the same time points as in the intervention group: 1 week, 4 weeks and 3, 6 and 12 months after randomisation. CONDITION: ; I68.0 Cerebral amyloid angiopathy PRIMARY OUTCOME: Change in cognitive performance, measured as the change in Mini‐Mental State Examination (MMSE), MoCA and DemTect scores at 3 months compared with baseline. SECONDARY OUTCOME: ‐ Changes in quality of life (SF‐36) ; ‐ Changes in neurofilament light chain concentration in cerebrospinal fluid ; ‐ Safety and tolerability parameters: incidence of postoperative complications (including wound healing disorders, lymphatic fistula, lymphoedema, infections, bleeding, vascular or nerve injury, anaesthesia‐related complications) ; ‐ Long‐term course of cognitive parameters and safety during follow‐up at 6 and 12 months INCLUSION CRITERIA: ‐ Diagnosed cerebral amyloid angiopathy with mild to moderate cognitive impairment (MMSE approx. 15–24) ‐ Age = 60 years ‐ Written informed consent of the participant if capable of consenting; in the case of disease‐related lack of capacity to consent, written informed consent of the legal representative, provided the requirements for study participation are otherwise met