1. A randomized, controlled clinical trial of plasma exchange with albumin replacement for Alzheimer's disease: Primary results of the AMBAR Study
- Author
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Michael Pfeffer, Suzanne Hendrix, Laura Núñez, Carlota Grifols, Montserrat Costa, Fernando Anaya, Oscar L. Lopez, José E. Gámez, Gerard Piñol-Ripoll, Dobri Kiprov, Jordi Bozzo, Mireia Torres, Antonio Páez, Jesús Lorites, Mercè Boada, Zbigniew M. Szczepiorkowski, María Paricio, Javier Olazarán, and Jose Lima
- Subjects
Male ,0301 basic medicine ,medicine.medical_specialty ,Epidemiology ,Clinical Dementia Rating ,medicine.medical_treatment ,Disease ,Placebo ,03 medical and health sciences ,Cellular and Molecular Neuroscience ,0302 clinical medicine ,Developmental Neuroscience ,Alzheimer Disease ,Albumins ,Internal medicine ,Humans ,Medicine ,Daily living ,Cognitive Dysfunction ,In patient ,albutein ,albumin ,Aged ,Aged, 80 and over ,Plasma Exchange ,Featured Articles ,business.industry ,Health Policy ,Albumin ,Immunoglobulins, Intravenous ,clinical trial ,Featured Article ,Alzheimer's disease ,Middle Aged ,Clinical trial ,Psychiatry and Mental health ,030104 developmental biology ,plasmapheresis ,Female ,Plasmapheresis ,Neurology (clinical) ,Geriatrics and Gerontology ,business ,030217 neurology & neurosurgery - 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
- Published
- 2020
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