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Drug Development.

Youssef M Seddeik1, Muataz El-Barbari1, Mohamed Nasim1

  • 1Faculty of Medicine Port Said Univeristy, Egypt, Port Said, Port Said, Egypt.

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|December 26, 2025
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Solanezumab, an anti-amyloid therapy for early Alzheimer's disease (AD), showed limited cognitive benefits despite worsening biomarker levels. This systematic review indicates solanezumab's restricted efficacy in treating AD patients.

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Area of Science:

  • Neurology
  • Pharmacology
  • Biochemistry

Background:

  • Alzheimer's disease (AD) is a leading cause of dementia, posing a significant global health challenge.
  • Solanezumab, an anti-amyloid monoclonal antibody (mAb), has been investigated for early AD treatment with mixed clinical outcomes.
  • Understanding solanezumab's precise effects on cognitive function and AD biomarkers is crucial.

Purpose of the Study:

  • To systematically review and meta-analyze randomized clinical trials (RCTs) evaluating solanezumab in early AD patients.
  • To assess the impact of solanezumab on cognitive function measures (MMSE, ADAS-Cog14, CDR-SB).
  • To investigate solanezumab's effect on key AD biomarkers (CSF Aβ40, Aβ42, Tau).

Main Methods:

  • Systematic literature search across major databases (PubMed, Scopus, Web of Science, Cochrane, ClinicalTrials.gov) up to December 2024.
  • Quality assessment of included RCTs using the Cochrane risk of bias 2 tool.
  • Statistical analysis performed using RevMan 5.3, focusing on cognitive tests and cerebrospinal fluid (CSF) biomarkers.

Main Results:

  • Six RCTs involving 5472 participants were analyzed.
  • Solanezumab treatment negatively impacted biomarker levels (CSF Aβ40, Aβ42, Tau), with no clinically significant results observed.
  • Limited, statistically significant improvements were noted in MMSE and ADAS-Cog14 scores, while CDR-SB showed no significant difference.

Conclusions:

  • Solanezumab demonstrates a limited efficacy in improving cognitive function for individuals with early Alzheimer's disease.
  • The observed worsening of biomarker levels suggests potential adverse effects or limited therapeutic impact of solanezumab.
  • Further research may be needed to clarify solanezumab's role and optimize treatment strategies for early AD.