This phase 2b/3 trial investigated the effects of plasma exchange (PE) with albumin replacement in patients with mild-to-moderate Alzheimer’s disease (AD). In the study, 347 patients were randomized into three PE treatment groups with varying doses of albumin and intravenous immunoglobulin, or a placebo group. Treatment involved six weeks of weekly conventional PE, followed by 12 months of monthly low-volume PE.
Key findings included:
- PE-treated patients showed significantly less decline in the Alzheimer’s Disease Cooperative Study–Activities of Daily Living (ADCS-ADL), with a 52% reduction in decline compared to placebo.
- There was also a trend for better scores in the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog), with a 66% reduction in decline.
- Patients with moderate AD (MMSE 18-21) showed notable improvements on both ADCS-ADL (61% less decline) and ADAS-Cog (61% less decline) compared to placebo, but no significant changes were observed in patients with mild AD (MMSE 22-26).
- PE-treated patients performed better on the Clinical Dementia Rating Sum of Boxes (CDR-sb) with a 71% reduction in decline and showed no decline on the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC).
The results suggest that PE with albumin replacement may slow cognitive and functional decline in moderate AD patients, although additional studies are recommended to confirm these findings.