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Dieter Willbold1,2,3, Janine Kutzsche4, Nicoleta Carmen Cosma5

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Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|December 25, 2025
PubMed
Summary
This summary is machine-generated.

The experimental drug PRI-002, targeting amyloid beta oligomers, showed good tolerability in patients with early Alzheimer's disease. While no biomarker changes were observed, significant memory improvements were noted in the PRI-002 group compared to placebo.

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Area of Science:

  • Neuroscience
  • Pharmacology
  • Biochemistry

Background:

  • Self-replicating amyloid beta (Aβ) oligomers are implicated in Alzheimer's disease (AD) pathogenesis, causing synaptotoxicity and cognitive decline.
  • The D-enantiomeric peptide PRI-002 is designed to disassemble toxic Aβ oligomers into monomers, acting as a potential therapeutic agent.
  • PRI-002 has demonstrated target engagement and efficacy in reversing cognitive deficits in preclinical models and is safe in healthy volunteers.

Purpose of the Study:

  • To evaluate the safety and tolerability of PRI-002 in patients with mild cognitive impairment (MCI) and mild dementia due to AD.
  • To explore the pharmacodynamics and potential efficacy of PRI-002 in this patient population.

Main Methods:

  • A randomized, placebo-controlled, double-blind Phase 1b study was conducted with 20 patients diagnosed with MCI to mild dementia due to AD.
  • Patients received either 300 mg of PRI-002 or a placebo daily for 28 days, with follow-up assessments on day 56.
  • Safety assessments included adverse events, ECG, EEG, MRI, and cerebrospinal fluid (CSF) biomarkers; efficacy was assessed via cognitive tests.

Main Results:

  • PRI-002 was well-tolerated, with no serious adverse events (SAEs) or significant changes in ECG, EEG, or MRI.
  • No significant changes were observed in CSF biomarkers including p-tau, t-tau, Aβ 1-40, Aβ 1-42, and Aβ oligomers.
  • Patients treated with PRI-002 demonstrated significant improvements in short-term memory compared to the placebo group (CERAD word list, day 56 vs. baseline, p<0.01).

Conclusions:

  • PRI-002 is safe and well-tolerated in patients with MCI and mild dementia due to AD.
  • The treatment did not yield significant changes in measured biomarkers after 28 days.
  • Significant memory improvements in the PRI-002 group suggest potential therapeutic efficacy, warranting further investigation in Phase 2 studies.