%0 Conference Paper
%A Peters, Oliver
%A Jürgens, Dagmar
%A Tischler, Gerhard
%A Brener, Alexander
%A Bartsch, Tina
%A Kauselmann, Gunther
%A Adermann, Knut
%A Zeiger, Kathrin
%A Lindner, Katja
%A Gabelich, Julie-Anne
%A Willbold, Dieter
%T Anti‐oligomeric PRI‐002 does not cause ARIA‐E in an ongoing Phase 2 trial
%J Alzheimer's and dementia
%V 21
%N S7
%@ 1552-5260
%M DZNE-2026-00010
%P e108724
%D 2025
%X BackgroundAmyloid related imaging abnormalities (ARIA) are a common side effect of monoclonal anti-amyloid antibodies and limit the benefit risk ratio. Here we investigate the safety and efficacy of the anti-oligomeric all-D-peptide PRI-002 in early AD. PRI-002 is an orally available, first in class compound developed to disassemble neurotoxic Aβ oligomers into non-toxic Aβ monomers. In a phase 1 B study PRI-002 has been shown to improve learning and memory function in early AD patients after 4 weeks of once-daily oral treatment and 4 weeks follow-up (Kutzsche et al., Nat. Commun. 2025).MethodPRImus-AD (NCT06182085) is an ongoing randomized, double-blind, placebo-controlled phase 2 study of PRI-002 in early symptomatic AD receiving either 300 mg, 600 mg or placebo every day for at least 48 weeks. Safety is measured by comparing adverse and serious adverse events in verum groups versus placebo. Primary efficacy outcome is CDR-SB. According to study protocol intense MRI monitoring to detect possible ARIA-E were performed during titration.Result304 patients 70.4±6.5 years on age, with a MMSE of 25.2±2.2, 155 with MCI (51.0
%B Alzheimer’s Association International Conference
%C 27 Jul 2025 - 31 Jul 2025, Toronto (Canada)
Y2 27 Jul 2025 - 31 Jul 2025
M2 Toronto, Canada
%F PUB:(DE-HGF)1 ; PUB:(DE-HGF)16
%9 AbstractJournal Article
%R 10.1002/alz70861_108724
%U https://pub.dzne.de/record/283114