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@INPROCEEDINGS{Peters:283114,
      author       = {Peters, Oliver and Jürgens, Dagmar and Tischler, Gerhard
                      and Brener, Alexander and Bartsch, Tina and Kauselmann,
                      Gunther and Adermann, Knut and Zeiger, Kathrin and Lindner,
                      Katja and Gabelich, Julie-Anne and Willbold, Dieter},
      title        = {{A}nti‐oligomeric {PRI}‐002 does not cause {ARIA}‐{E}
                      in an ongoing {P}hase 2 trial},
      journal      = {Alzheimer's and dementia},
      volume       = {21},
      number       = {S7},
      issn         = {1552-5260},
      reportid     = {DZNE-2026-00010},
      pages        = {e108724},
      year         = {2025},
      abstract     = {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 $(51.0\%)$ and 149
                      $(49.0\%)$ with mild dementia were randomized. CDR-SB at
                      baseline was 3.3±1.4 and RBANS-DMI 54.8±12.7. 208 patients
                      have at least one APOE4 allele $(68.4\%).$ After 90
                      patients, irrespective of the treatment arm, had passed the
                      first 24 weeks of treatment, the incidence of ARIA was
                      evaluated. Within these 90 patients ARIA-E occurred in 4
                      $(4.4\%)$ and ARIA-H were detected in 13 $(14.4\%)$
                      subjects. This incidence is in line with large observational
                      cohorts like ADNI. An unblinded DSMB reviewed the ARIA
                      incidence in all three study arms and recommended to stop
                      the intense ARIA monitoring for the rest of the study, since
                      no imbalance was detected.ConclusionIn an ongoing phase 2
                      trial with oral PRI-002 that was designed to disassemble
                      synaptotoxic Aβ aggregates into harmless Aβ monomers, the
                      study drug is safe and in detail does not cause ARIA
                      incidents Efficacy data are expected in 2026.},
      month         = {Jul},
      date          = {2025-07-27},
      organization  = {Alzheimer’s Association
                       International Conference, Toronto
                       (Canada), 27 Jul 2025 - 31 Jul 2025},
      cin          = {AG Peters},
      ddc          = {610},
      cid          = {I:(DE-2719)5000000},
      pnm          = {353 - Clinical and Health Care Research (POF4-353)},
      pid          = {G:(DE-HGF)POF4-353},
      typ          = {PUB:(DE-HGF)1 / PUB:(DE-HGF)16},
      doi          = {10.1002/alz70861_108724},
      url          = {https://pub.dzne.de/record/283114},
}