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The AMBAR (Alzheimer Management By Albumin Replacement) study is a multicenter, randomized, placebo-controlled phase IIb/III trial investigating the effects of plasma exchange (PE) with therapeutic albumin replacement in patients with mild to moderate Alzheimer’s disease (AD). Previous studies indicated that PE with albumin may help remove amyloid-beta from plasma and cerebrospinal fluid, leading to improved memory, language function, and stable brain perfusion even after stopping treatment.

In the AMBAR trial, 496 patients were enrolled across 41 centers in Spain and the USA, with 347 randomized into one of three treatment groups or a control group. The treatment involves an initial 6-week intensive stage, followed by a 12-month maintenance phase. The primary outcomes focus on changes in cognitive (ADAS-Cog) and functional (ADCS-ADL) scores from baseline. Secondary outcomes include additional cognitive, functional, behavioral, and disease progression assessments, along with measurements of amyloid-beta and tau levels, and structural and functional brain changes.

The study’s design aims to demonstrate that PE with albumin can slow cognitive and functional decline in AD patients, providing a potentially new therapeutic approach for managing the disease.