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New Alzheimer's disease (AD) therapies combine novel anti-tau antibodies and focused ultrasound. This approach showed promise in restoring proteostasis and improving memory in mouse models, with early human trials demonstrating safety.

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Area of Science:

  • Neuroscience
  • Immunotherapy
  • Medical Devices

Background:

  • Current Alzheimer's disease (AD) therapies provide limited symptomatic relief.
  • Approved anti-amyloid-β antibodies require further validation for real-world efficacy.
  • Alternative therapeutic strategies are urgently needed for Alzheimer's disease.

Purpose of the Study:

  • To explore complementary treatment strategies for Alzheimer's disease (AD).
  • To target amyloid and tau deposition, and associated cognitive impairment.
  • To develop novel anti-tau immunotherapies and utilize low-intensity ultrasound for drug delivery and neuromodulation.

Main Methods:

  • Developed and tested a novel anti-tau antibody (RNJ1) against a benchmark antibody (HJ8.5).
  • Assessed the efficacy of scanning ultrasound (SUS) in an amyloid-depositing mouse model (APP23).
  • Developed JAM-1 targeting nanobodies to facilitate blood-brain barrier (BBB) opening for drug delivery.
  • Built an ISO13485-certified investigational device (UltraThera Pilot) and conducted a safety trial in AD patients.

Main Results:

  • The novel anti-tau antibody RNJ1 outperformed HJ8.5 in vitro and in vivo.
  • Proteostasis restoration was identified as a novel efficacy metric for tau immunotherapy.
  • Scanning ultrasound (SUS) without BBB opening improved memory deficits in APP23 mice without reducing amyloid-β burden.
  • A safety trial in 12 AD patients demonstrated the investigational device's safety, tolerability, and feasibility.

Conclusions:

  • Cognitive improvement in Alzheimer's disease (AD) may be dissociated from amyloid-β (Aβ) clearance.
  • Findings have implications for designing future ultrasound-based AD therapy trials.
  • A new metric for evaluating brain-targeting immunotherapies was identified.