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Drug Development.

Noor Salaymeh1, Akash G Patel1, Pramod N Nehete2

  • 1NYU Grossman School of Medicine, New York, NY, USA.

Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|December 26, 2025
PubMed
Summary
This summary is machine-generated.

This study shows that CpG-ODN 1018 is a safe immunomodulatory approach for treating brain aging and dementia-related pathology, like cerebral amyloid angiopathy (CAA), in non-human primates (NHPs). Further research will validate its clinical application.

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Area of Science:

  • Neuroscience
  • Immunology
  • Gerontology

Background:

  • Non-human primates (NHPs) are crucial models for brain aging research, particularly for conditions not well-represented in rodents.
  • Squirrel monkeys (SQMs) with sporadic Alzheimer's disease (AD)-related pathology and cerebral amyloid angiopathy (CAA) were previously shown to benefit from TLR9 agonist CpG-ODN 2006.
  • CpG-ODN 1018, with a strong safety record in clinical trials, was selected to evaluate its efficacy and safety in ameliorating dementia-related pathology.

Purpose of the Study:

  • To assess the immunostimulatory patterns of CpG-ODN 1018 in a NHP model.
  • To monitor disease progression using behavioral measures and fluid/imaging biomarkers.
  • To evaluate the safety and efficacy of CpG-ODN 1018 in ameliorating AD-related pathology, specifically CAA.

Main Methods:

  • Geriatric SQMs received CpG-ODN or saline injections every 5 weeks.
  • Immune response was analyzed using Nanostring nCounter System.
  • Plasma and CSF biomarkers (AD pathogenesis, neurodegeneration, neuroinflammation) were measured using SIMOA and Luminex.
  • Cognitive function was assessed using a touchscreen-based Automated Cognitive Testing System (ACTS).

Main Results:

  • CpG-ODN administration upregulated IFN-inducible and cytokine-chemokine genes (e.g., IFIT2, Mx2/MxB, GBP1, MIG, IP10, MCP1).
  • Preliminary biomarker analyses (Ab40, Ab42, NfL, GFAP, etc.) showed no significant differences between groups or over time.
  • ACTS demonstrated potential for longitudinal cognitive monitoring in SQMs; no amyloid-related imaging abnormalities (ARIA) were observed, confirming safety.

Conclusions:

  • CpG-ODN 1018 demonstrated immunostimulatory effects and was safe in NHPs, with no observed ARIA.
  • The study supports the concept of immunomodulation as a safe therapeutic strategy for dementia-related pathology, particularly CAA.
  • Further validation of CpG-ODN 1018 for potential clinical application in treating dementia is warranted.