An Open-Label, Pilot Study of Daratumumab SC in Mild to Moderate Alzheimer's Disease

J Alzheimers Dis Rep. 2024 Jul 31;8(1):1111-1114. doi: 10.3233/ADR-240089. eCollection 2024.

Abstract

We conducted a small, open-label, pilot study of daratumumab to explore target engagement, safety, and potential efficacy in patients with mild to moderate Alzheimer's disease. Daratumumab SC 1800 mg was given subcutaneously weekly for 8 weeks, then every 2 weeks for 16 weeks. Flow cytometry to measure the CD38+ proportion of CD8 + CD4- T cells and cognitive assessments were performed at baseline, day 176, and day 246. Daratumumab significantly reduced CD38 + CD8 + CD4- T cells after 24 weeks and this effect persisted 11 weeks thereafter. There was no hematological toxicity or unexpected adverse events. Responder analysis showed no improvement on cognitive outcome measures.

Keywords: Alzheimer’s disease; CD38; NAD; daratumumab; energy metabolism; neuroinflammation.