Abstract

There are currently no new convenient patient-centric oral disease-modifying treatments approved for Alzheimer’s disease (AD) without the requirement of complex logistical resources and added personnel for drug administration and expensive safety monitoring.
Recently published in JPAD, blarcamesine demonstrated in a randomized, double-blind, placebo-controlled, 48-week Phase IIb/III trial (ANAVEX2-73-AD-004) promising clinical results (numerically superior to injectable infusion mAbs) with meaningful improvements on top of standard of care (donepezil, galantamine or rivastigmine, etc.) significant clinical benefit with slowed clinical progression by 36.3% at 48 weeks for all patients as well as by 49.8% at 48 weeks for the prespecified patient group (~70% of population), as measured by the primary cognitive endpoint ADAS-Cog13 and also on predesignated biomarkers. Blarcamesine demonstrated a strong safety profile with no neuroimaging-related side effects. There were no deaths related to the study drug. Study publication (link).
The trial inclusion requirements were readily manageable for both the patients and the families with no mandatory invasive assessments required. The emphasis was on the National Institute on Aging (NIA) – Alzheimer’s Association criteria for diagnosis of early-stage mild dementia due to AD or mild cognitive impairment due to AD. The same accommodating procedures would be followed upon potential market approval.
The advantage for the patient would be being helped timely without delays and constrains by cumbersome and limiting inconvenient complex diagnostics procedures allowing for quicker time-sensitive access to a new oral treatment with continued focus on the individual patient.
The advantage for the family would be less caregiver stress, and likely less financial strain with no need to arrange for constant transportation and no impact on own work schedule.
The advantage for the physician would be no logistical barriers to treatment with no need to arrange or schedule complex, invasive PET scans, lumbar puncture (spinal tap) or repeated MRIs.
In summary, the impact on daily life is extended by time saved with oral Alzheimer's treatment blarcamesine allowing for longer independence of loved ones  with safer and better outcome  while allowing efficiency, accessibility, and ease for patients and families.