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

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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.

authors

  • Paez, Hector Antonio
  • 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

publication date

  • October 2020