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Drug Development.

Marwan N Sabbagh1, Stephen Macfarlane2, Audrey Gabelle3

  • 1Barrow Neurological Institute, Phoenix, AZ, USA.

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

Blarcamesine, an oral small molecule, shows significant efficacy and a favorable safety profile for early Alzheimer's disease (AD). Early treatment initiation with blarcamesine (BLC) is crucial for meaningful clinical benefits in AD patients.

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Area of Science:

  • Neuroscience
  • Pharmacology
  • Gerontology

Background:

  • No approved oral disease-modifying small molecule therapies exist for early Alzheimer's disease (AD).
  • Blarcamesine (BLC) is an orally bioavailable small molecule that enhances autophagy via SIGMAR1 activation, restoring cellular homeostasis in early AD.

Purpose of the Study:

  • To evaluate the safety and efficacy of oral blarcamesine (BLC) in early Alzheimer's disease (AD).
  • To assess the long-term effects of early treatment initiation with blarcamesine (BLC).

Main Methods:

  • The ATTENTION-AD study was an open-label extension of a Phase IIb/III trial involving 508 early AD participants.
  • Oral blarcamesine (BLC) was administered once daily for up to 144 weeks.
  • Delayed-start analysis assessed treatment effects up to 192 weeks.

Main Results:

  • Blarcamesine (BLC) demonstrated good efficacy and safety, with a manageable and transient primary adverse event (dizziness).
  • A longer titration period in ATTENTION-AD significantly reduced dizziness frequency compared to the prior study (9.6% vs. 25.2%).
  • Delayed-start analysis showed significant cognitive and functional improvements at 192 weeks (ADAS-Cog13, ADCS-ADL), highlighting the importance of early intervention.

Conclusions:

  • Blarcamesine (BLC) significantly reduces clinical decline, offering meaningful benefits for early Alzheimer's disease (AD) patients.
  • Blarcamesine (BLC) exhibits a favorable safety profile, with no treatment-related deaths or neuroimaging adverse events over 4 years.
  • Blarcamesine (BLC) represents a potentially effective, safe, and scalable oral treatment option for early AD.