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A randomized, controlled clinical trial of plasma exchange with albumin replacement for Alzheimer's disease: Primary results of the AMBAR Study.

Research Center and Memory Clinic, Fundació ACE, Institut Català de Neurociències Aplicades - Universitat Internacional de Catalunya, Barcelona, Spain. Centro de Investigación Biomédica en Red de Enfermedades Neurodegenerativas (CIBERNED), Instituto de Salud Carlos III, Madrid, Spain. Departments of Neurology and Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA. Neurology Service, Hospital General Universitario Gregorio Marañón, Madrid, Spain. Memory Disorders Unit - HM Hospitals, Madrid, Spain. Alzheimer's Research Group, Grifols, Barcelona, Spain. Medical Services, Allied Biomedical Research Institute, Inc., Miami, Florida, USA. Center for Prevention of Alzheimer´s Disease, Miami Dade Medical Research Institute, Miami, Florida, USA. Medical Services, L&L Research Choices, Inc., Miami, Florida, USA. Seizure Disorders Unit, Clinical Neuroscience Research, IRBLleida-Hospital Universitari Santa Maria, Lleida, Spain. Psychiatry Department, Galiz Research, Hialeah, Florida, USA. Nephrology Service, Hospital General Universitario Gregorio Marañón, Madrid, Spain. Apheresis Care Group and Fresenius Medical Care, San Francisco, California, USA. American Red Cross Southern Blood Services Region, Atlanta, Georgia, USA. Department of Pathology and Laboratory Medicine, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, USA. Pentara Corporation, Salt Lake City, Utah, USA.

Alzheimer's & dementia : the journal of the Alzheimer's Association. 2020;(10):1412-1425
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Abstract

INTRODUCTION This phase 2b/3 trial examined the effects of plasma exchange (PE) in patients with mild-to-moderate Alzheimer's disease (AD). METHODS Three hundred forty-seven patients (496 screened) were randomized (1:1:1:1) into three PE treatment arms with different doses of albumin and intravenous immunoglobulin replacement (6-week period of weekly conventional PE followed by a 12-month period of monthly low-volume PE), and placebo (sham). RESULTS PE-treated patients performed significantly better than placebo for the co-primary endpoints: change from baseline of Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL; P = .03; 52% less decline) with a trend for Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog; P = .06; 66% less decline) scores at month 14. Moderate-AD patients (baseline Mini-Mental State Examination [MMSE] 18-21) scored better on ADCS-ADL (P = .002) and ADAS-Cog (P = .05), 61% less decline both. There were no changes in mild-AD patients (MMSE 22-26). PE-treated patients scored better on the Clinical Dementia Rating Sum of Boxes (CDR-sb) (P = .002; 71% less decline) and Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) (P < .0001; 100% less decline) scales. DISCUSSION This trial suggests that PE with albumin replacement could slow cognitive and functional decline in AD, although further studies are warranted.

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