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Drug Development.

Marwan N Sabbagh1, Audrey Gabelle2, Timo Grimmer3

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

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

Precision medicine in Alzheimer's disease (AD) shows promise. Blarcamesine, targeting the Sigma-1 receptor (SIGMAR1), demonstrated enhanced efficacy in patients with the wild-type (WT) SIGMAR1 genotype, supporting personalized treatment strategies.

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Area of Science:

  • Neuroscience
  • Pharmacology
  • Genetics

Background:

  • Precision medicine tailors Alzheimer's disease (AD) treatments based on individual profiles.
  • This approach optimizes outcomes by identifying patient subgroups likely to benefit from specific therapies.

Purpose of the Study:

  • To evaluate the efficacy of blarcamesine, a Sigma-1 receptor (SIGMAR1) modulator, in Alzheimer's disease patients.
  • To investigate the role of the SIGMAR1 genotype in predicting response to blarcamesine treatment.

Main Methods:

  • Conducted a Phase IIb/III clinical trial (ANAVEX2-73-AD-004) using oral blarcamesine.
  • Performed pre-specified efficacy analyses based on the SIGMAR1 genotype (wild-type vs. others).

Main Results:

  • Blarcamesine significantly improved cognitive and functional measures (ADAS-Cog13, CDR-SB) compared to placebo in all participants.
  • Patients with the homozygous wild-type (WT) SIGMAR1 genotype showed substantially greater improvement versus placebo (49.8% for ADAS-Cog13, 33.7% for CDR-SB).

Conclusions:

  • The SIGMAR1 genotype is a key determinant of blarcamesine efficacy in AD, highlighting its potential in precision medicine.
  • Personalized therapies targeting specific molecular profiles offer more substantial and sustained benefits for AD patients.
  • Realizing the full potential of precision medicine in AD requires addressing challenges in cost, data privacy, ethics, and access.