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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
Author(s) -
Boada Mercè,
López Oscar L.,
Olazarán Javier,
Núñez Laura,
Pfeffer Michael,
Paricio María,
Lorites Jesús,
PiñolRipoll 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
Publication year - 2020
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1002/alz.12137
Subject(s) - placebo , medicine , cognitive decline , clinical dementia rating , alzheimer's disease , dementia , clinical trial , clinical global impression , clinical endpoint , disease , mini–mental state examination , randomized controlled trial , gastroenterology , psychology , physical therapy , pathology , alternative medicine
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.