A randomized, controlled clinical trial of plasma exchange with albumin replacement for Alzheimer's disease: Primary results of the AMBAR Study.
Alzheimers Dement
; 16(10): 1412-1425, 2020 10.
Article
en En
| MEDLINE
| ID: mdl-32715623
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 (1111) 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.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Intercambio Plasmático
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Enfermedad de Alzheimer
Tipo de estudio:
Clinical_trials
Límite:
Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Año:
2020
Tipo del documento:
Article