This phase 2b/3 trial evaluated the effects of plasma exchange (PE) with albumin replacement on patients with mild-to-moderate Alzheimer’s disease (AD). A total of 347 patients were randomized into three treatment groups with varying doses of albumin and intravenous immunoglobulin (IVIG) or a placebo group. The treatment included an initial 6-week period of weekly PE, followed by 12 months of monthly low-volume PE.
Key Findings:
- PE-treated patients showed significantly less decline in daily living activities (ADCS-ADL) and a trend toward improvement in cognitive scores (ADAS-Cog), with a 52% and 66% reduction in decline, respectively, at 14 months.
- Moderate AD patients (MMSE 18-21) experienced notable improvements, with a 61% reduction in decline in both ADCS-ADL and ADAS-Cog scores.
- PE-treated patients performed better on the Clinical Dementia Rating Sum of Boxes (CDR-sb), with 71% less decline, and showed no decline on the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC).
Conclusion: The study suggests that PE with albumin replacement may slow cognitive and functional decline in AD, especially in moderate cases, although further research is needed to confirm these findings.