Immunoadsorption for Treatment of Patients with Suspected Alzheimer Dementia and Agonistic Autoantibodies against Alpha1a-Adrenoceptor-Rationale and Design of the IMAD Pilot Study.

Autor: Stracke S; Department for Internal Medicine A, Nephrology, University Medicine Greifswald, Ferdinand-Sauerbruch-Straße, 17475 Greifswald, Germany., Lange S; Institute of Diagnostic Radiology and Neuroradiology, University Medicine Greifswald, 17475 Greifswald, Germany., Bornmann S; Department of Neurology, University Medicine Greifswald, 17475 Greifswald, Germany., Kock H; Strategic Research Management, University Medicine Greifswald, 17475 Greifswald, Germany., Schulze L; Department of Psychiatry and Psychotherapy, University Medicine Greifswald, 17475 Greifswald, Germany., Klinger-König J; Department of Psychiatry and Psychotherapy, University Medicine Greifswald, 17475 Greifswald, Germany., Böhm S; Coordinating Centre for Clinical Trials, University Medicine Greifswald, 17475 Greifswald, Germany., Vogelgesang A; Department of Neurology, University Medicine Greifswald, 17475 Greifswald, Germany., von Podewils F; Department of Neurology, University Medicine Greifswald, 17475 Greifswald, Germany., Föel A; Department of Neurology, University Medicine Greifswald, 17475 Greifswald, Germany.; German Center for Neurodegenerative Diseases (DZNE), 17475 Rostock/Greifswald, partner site Greifswald, Germany., Gross S; Department of Internal Medicine B, University Medicine Greifswald, Ferdinand-Sauerbruch-Straße, 17475 Greifswald, Germany.; German Centre for Cardiovascular Research (DZHK), 17475 Greifswald, Germany., Wenzel K; Berlin Cures GmbH, 13125 Berlin, Germany., Wallukat G; Berlin Cures GmbH, 13125 Berlin, Germany., Prüss H; German Center for Neurodegenerative Diseases (DZNE) Berlin, 10117 Berlin, Germany.; Department of Neurology and Experimental Neurology, Charité-Universitätsmedizin Berlin, 10117 Berlin, Germany., Dressel A; Department of Neurology, Carl-Thiem-Klinikum, 03048 Cottbus, Germany., Kunze R; Science Office, Hessenhagen 2, 17268 Flieth-Stegelitz, Germany., Grabe HJ; Department of Psychiatry and Psychotherapy, University Medicine Greifswald, 17475 Greifswald, Germany.; German Center for Neurodegenerative Diseases (DZNE), 17475 Rostock/Greifswald, partner site Greifswald, Germany., Langner S; Institute of Diagnostic Radiology and Neuroradiology, University Medicine Greifswald, 17475 Greifswald, Germany.; Institute of Diagnostic and Interventional Radiology, University Medicine Rostock, 18057 Rostock, Germany., Dörr M; Department of Internal Medicine B, University Medicine Greifswald, Ferdinand-Sauerbruch-Straße, 17475 Greifswald, Germany.; German Centre for Cardiovascular Research (DZHK), 17475 Greifswald, Germany.
Jazyk: angličtina
Zdroj: Journal of clinical medicine [J Clin Med] 2020 Jun 19; Vol. 9 (6). Date of Electronic Publication: 2020 Jun 19.
DOI: 10.3390/jcm9061919
Abstrakt: Background: agonistic autoantibodies (agAABs) against G protein-coupled receptors (GPCR) have been linked to cardiovascular disease. In dementia patients, GPCR-agAABs against the α1- and ß2-adrenoceptors (α1AR- and ß2AR) were found at a prevalence of 50%. Elimination of agAABs by immunoadsorption (IA) was successfully applied in cardiovascular disease. The IMAD trial (Efficacy of immunoadsorption for treatment of persons with Alzheimer dementia and agonistic autoantibodies against alpha1A-adrenoceptor) investigates whether the removal of α1AR-AABs by a 5-day IA procedure has a positive effect (improvement or non-deterioration) on changes of hemodynamic, cognitive, vascular and metabolic parameters in patients with suspected Alzheimer's clinical syndrome within a one-year follow-up period.
Methods: the IMAD trial is designed as an exploratory monocentric interventional trial corresponding to a proof-of-concept phase-IIa study. If cognition capacity of eligible patients scores 19-26 in the Mini Mental State Examination (MMSE), patients are tested for the presence of agAABs by an enzyme-linked immunosorbent assay (ELISA)-based method, followed by a bioassay-based confirmation test, further screening and treatment with IA and intravenous immunoglobulin G (IgG) replacement. We aim to include 15 patients with IA/IgG and to complete follow-up data from at least 12 patients. The primary outcome parameter of the study is uncorrected mean cerebral perfusion measured in mL/min/100 gr of brain tissue determined by magnetic resonance imaging with arterial spin labeling after 12 months.
Conclusion: IMAD is an important pilot study that will analyze whether the removal of α1AR-agAABs by immunoadsorption in α1AR-agAAB-positive patients with suspected Alzheimer's clinical syndrome may slow the progression of dementia and/or may improve vascular functional parameters.
Databáze: MEDLINE
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