Drug Development

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.