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

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.
Competing Interests: M.L. Gordon has received compensation for participating in Advisory Board meetings for Corium and Labcorp. He has been a clinical trial site Principal Investigator for AbbVie, Alector, Bristol Myers Squibb, Eisai, and Novo Nordisk (payments made to institution). J. Koppel has received grant support from NIA, NIMH, and Alzheimer’s Foundation of America, and has been a clinical trial site Principal Investigator for Karuna and Otsuka (payments made to institution). J. Gomar has received grant support from NIA and Alzheimer’s Association (payments made to institution). E. Christen, L. Keehlisen, M. Gong, F. Lam, and L. Giliberto have no disclosures.
(© 2024 – The authors. Published by IOS Press.)