Immunoadsorption for Treatment of Alzheimer's Disease

Exclusion Criteria

• •Haemanalysis:
• •* Presence of autoantibodies against the N-methyl-D-aspartate (NMDA) receptor
• •* Defective blood coagulation at time of inclusion
• •* Severe protein deficiency disorders
• •* manifest Vitamin/Folic acid deficiency (substitution allowed)
• •Active infectious disease, or signs of ongoing infection with C-reactive protein (CRP) \>10mmol/L
• •Impaired renal function (serum creatinine \>220 μmol/L)
• •Any disease requiring immunosuppressive drugs or therapeutic antibodies
• •Non curative treated malignant disease or another life-threatening disease with poor prognosis (survival less than 2 years), except for basal-cell carcinoma
• •Unstable angina pectoris, atrioventricular block (AV block) 2./3. degree or symptomatic sick sinus syndrome without implanted pacemaker, history of myocardial infarct, bypass or other revascularization measures, valvular heart defect (≥ 2. Degree)
• •Severely reduced left ventricular systolic function (LVEF \< 30%) and/or heart failure symptoms according to New York Heart Association (NYHA) class III/IV
• •Clinical manifestation of arterial disease, vascular surgery: No Arteria Carotis Interna (ACI) Stenosis \> 60%, peripheral artery occlusive disease (PAOD) \> IIb, NASCET, no clinical manifest apparent stroke in anamnesis, MRI: no diffusion disorder, no expired territorial stroke
• •Endocrine disorder excluding diabetes mellitus
• •Severe hepatic damages (CHILD-Score \< 4)
• •Severe mental disorders (bipolar disorder, schizophrenia, depression) requiring treatment
• •Alcohol or drug abuse
• •Drug therapy against dementia since less than 3 months
• •Psychopharmacological drug therapy since less than 3 months
• •Dialysis requirement
• •MRI contraindications (e.g. heart pacemaker)
• •Legal tutelage
• •Previous treatments with IA or immunoglobulin
• •Inability to undergo the study procedure (IA on five consecutive days with subsequent Immunoglobulin G (IgG) substitution)
• •treatment with angiotensin-converting-enzyme inhibitors (ACE inhibitors) during the IA (angiotensin receptor blockers (AT-blockers) possible)
• •Participation in any other clinical/interventional study within less than 30 days prior to screening date