A randomized, controlled clinical trial of plasma exchange with albumin replacement for Alzheimer's disease: Primary results of the AMBAR Study. Issue 10 (27th July 2020)

• Record Type: Journal Article
• Authors: Boada, Mercè; López, Oscar L.; Olazarán, Javier; Núñez, Laura; Pfeffer, Michael; Paricio, María; Lorites, Jesús; Piñol‐Ripoll, Gerard; Gámez, José E.; Anaya, Fernando; Kiprov, Dobri; Lima, José; Grifols, Carlota; Torres, Mireia; Costa, Montserrat; Bozzo, Jordi; Szczepiorkowski, Zbigniew M.; Hendrix, Suzanne; Páez, Antonio
• Is Part Of: Alzheimer's & dementia. Volume 16:Issue 10(2020)
• Page Start: 1412
• Page End: 1425
• Publication Date: 2020-07-27
• Subjects: albumin -- albutein -- Alzheimer's disease -- clinical trial -- plasma exchange -- plasmapheresis; Alzheimer's disease -- Periodicals; Alzheimer Disease -- Periodicals; Dementia -- Periodicals; Démence; Maladie d'Alzheimer; Périodique électronique (Descripteur de forme); Ressource Internet (Descripteur de forme); 616.83
• DOI: 10.1002/alz.12137
• Languages: English
• ISSNs: 1552-5260

Abstract

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.