Long-Term Health Outcomes of Lecanemab in Patients with Early Alzheimer’s Disease Using Simulation Modeling

Abstract

Introduction Alzheimer’s disease (AD) is a progressive, neurodegenerative disease and is the most common cause of dementia. Lecanemab is a humanized monoclonal antibody targeting amyloid protofibrils for the treatment of early AD. In the phase II BAN2401-G000-201 trial (NCT01767311), lecanemab reduced amyloid accumulated in the brain and slowed progression on key global and cognitive scales evaluating efficacy after 18 months of treatment. Methods A disease simulation model was used to predict the long-term clinical outcomes of lecanemab for patients with early AD [i.e., mild cognitive impairment (MCI) due to AD and mild AD dementia] on the basis of BAN2401-G000-201 trial data and published literature. The model captures the pathophysiology and management of AD, with a focus on simulating the effects of disease modification and early intervention on disease progression. The model compares lecanemab in addition to standard of care (SoC) versus SoC alone. Results Lecanemab treatment was estimated to slow the rate of disease progression, resulting in an extended duration of MCI due to AD and mild AD dementia and shortened duration in moderate and severe AD dementia. The mean time to mild, moderate, and severe AD dementia was longer for patients in the lecanemab + SoC group than for patients in the SoC group by 2.51, 3.13, and 2.34 years, respectively. On base-case analysis, lecanemab was associated with 0.73 incremental life years (LY) and 0.75 incremental quality-adjusted LYs (QALY), and the caregiver QALYs lost was reduced by 0.03 years. The model also predicted a lower lifetime probability of admission to institutional care in lecanemab + SoC versus SoC group (25% versus 31%). Conclusion The model results demonstrate the potential clinical value of lecanemab for patients with early AD and how it can slow the rate of disease progression and reduce the lifetime probability for institutionalized care. Supplementary Information The online version contains supplementary material available at 10.1007/s40120-022-00350-y.

A New Hope in Alzheimer's Treatment; Lecanemab

“…It is anticipated that approval of lecanemab would restrict its use to patients in the early stages of Alzheimer's disease [14]. They account for around 2 million of the total 6 million patients diagnosed with the condition [16].…”

The mechanism and efficacy of GLP-1 receptor agonists in the treatment of Alzheimer’s disease

“…Clinical studies have been reported that anti-Aβ protofibril antibody lecanemab has produced modest but highly statistically significant results in a trial. The drug met its primary endpoint of slowing cognitive decline in individuals with mild cognitive impairment (MCI), a clinical presentation thought to be a precursor to AD, and those with mild AD ( 32 , 33 ).…”

Validity and reliability of a computerized cognitive function evaluation battery (CogEvo) as a screening tool

“…Drugs that improve the symptoms have been used in such cases to suppress exacerbation and delay the progression of cognitive dysfunction. Recently, new amyloid disease modifiers that control progression have been developed 2–4 . The first step in diagnosing cognitive dysfunction is to identify mild cognitive impairment (MCI) or the cognitively normal (CN) before the onset of AD, and then begin the treatment accordingly 4–6 …”