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Drug Development.

Suvarna Alladi1, Samim M Mondal2, Faheem Arshad3

  • 1National Institute of Mental Health and Neurosciences [NIMHANS], Bengaluru, Karnataka, India.

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Lecanemab treatment eligibility is limited for many Alzheimer's disease patients in low-resource settings. Enhancing biomarker access and early detection is crucial for equitable access to new Alzheimer's therapies.

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Area of Science:

  • Neurology
  • Pharmacology
  • Public Health

Background:

  • Lecanemab, an amyloid-targeting monoclonal antibody, offers disease-modifying treatment for Alzheimer's disease (AD).
  • Accessibility in low- and middle-income countries (LMICs) is hindered by biomarker limitations, cost, and trial diversity issues.
  • This study assesses lecanemab eligibility for Mild Cognitive Impairment (MCI) and AD patients in a LMIC clinic.

Purpose of the Study:

  • To evaluate lecanemab eligibility among MCI and AD patients in a Cognitive Disorders Clinic (CDC) within a LMIC.
  • To assess eligibility based on clinical and imaging criteria used in lecanemab trials.
  • To identify barriers to lecanemab treatment in a LMIC setting.

Main Methods:

  • Retrospective review of dementia patient data from the CDC registry (May 2016-May 2021).
  • Inclusion criteria mirrored lecanemab clinical trial requirements.
  • Eligibility assessed using Clinical Dementia Rating (CDR), Mini Mental Status Examination (MMSE), and MRI reviews; plasma/brain amyloid biomarkers were unavailable.

Main Results:

  • Out of 1448 dementia patients, 643 (44.4%) had MCI or AD.
  • Applying CDR, age, and MMSE criteria excluded a significant portion of patients.
  • Primary exclusion factors were advanced disease stage (40%), comorbidities (30%), and cerebral microbleeds (20%).
  • Only 134 patients (20.8% of MCI/AD cases) were potentially eligible for lecanemab.

Conclusions:

  • A substantial majority (80.75%) of dementia patients in this LMIC setting may be ineligible for lecanemab.
  • Eligibility hinges on biomarker availability and diagnostic resources.
  • Equitable access to emerging AD therapies requires improved biomarker accessibility, early detection, and cost-effective strategies in LMICs.