Hope or Hype for People With Alzheimer’s Disease 

What is Alzheimer’s? 

Alzheimer’s disease treatments are of high priority. As of 2021, approximately 55 million people worldwide live with Alzheimer’s or other neurodegenerative dementias.¹

Alzheimer’s is a progressive neurodegenerative disease that causes loss or destruction of neurons in the brain. Neurons are the fundamental cells communicating information to, from, and within the brain. Early symptoms of Alzheimer’s can include:

• Struggles with remembering where you placed things or where they usually go,
• Struggles with finding common words,
• And detriments to intellectual functions. 

The results indicate the provoking factor of the disease is the accumulation of protein fragments in the brain called tau and beta-amyloid .² Alzheimer’s is not a normal part of aging, and early detection can improve health outcomes. 

Exploring Alzheimer’s treatments

Aducanumab 

Aducanumab targets the triggers of the disease rather than the symptoms.³ Since 2021, the U.S. Food and Drug Administration (FDA) approved aducanumab for use in reducing symptoms of Alzheimer’s and aducanumab became the newest treatment since 2003.³ Pharmaceutical interventions have been developed to maintain quality of life and alleviate disease symptoms; however, Alzheimer’s remains incurable. 

The approval of aducanumab came with controversies. The FDA’s advisory committee advised the FDA that clinical trial data was inconclusive in slowing cognitive decline.⁴ The inconclusive data was due to the early termination of the trials. The early termination was because of the unlikeliness of the drug to show cognitive benefit.⁵ Only one subgroup of participants in the clinical trial showed a slowdown in cognitive decline initiating a re-analysis by Biogen to seek FDA approval.⁶ 

Lecanemab 

In September 2022, a new drug candidate was introduced to the market. This drug promises to slow the cognitive decline associated with Alzheimer’s disease. Lecanemab has shown strong clinical trial results in a sizeable late-stage trial.⁶ 

Lecanemab clears the clumps of protein from the brain associated as causative factors for Alzheimer’s disease.⁶ Compared to aducanumab, lecanemab clinical trials ran uninterrupted and slowed the decline to a statistically relevant extent.⁶ 

Both medications had reports of adverse events of brain swelling; however, lecanemab had fewer reports (20%) made versus aducanumab (40%).⁶ The FDA is currently examining lecanemab for accelerated approval based on clinically significant phase two trial results.⁶ 

Conclusions

These medications do not serve as a cure. Pharmaceuticals give patients hope in preserving their independence and maintaining cognitive function. Although lecanemab has shown promising results in clinical trials FDA has not given its approval for use. In contrary, aducanumab’s FDA-approval is under the accelerated approval pathway for serious medical conditions with an unmet need.⁷ A multi-targeted drug approach may also be needed to address the different types of proteins leading to Alzheimer’s disease.⁶

Individuals with Alzheimer’s require additional support beyond medications.⁶ Interventions should include educational initiatives and guidance on managing disease progression even with FDA approval.⁶ 

References 

1. Gauthier S, Rosa-Neto P, Morais JA, & Webster C. 2021. World Alzheimer report 2021: Journey through the diagnosis of dementia. London, England: Alzheimer’s Disease International. https://www.alzint.org/u/World-Alzheimer-Report-2021.pdf
2. Alzheimer’s Association. 2019 Alzheimer’s disease facts and figures. Alzheimer’s & Dementia. 2019;15:321-387. https://alz.org/media/Documents/alzheimers-facts-and-figures-2019-r.pdf
3. FDA grants accelerated approval for Alzheimer’s drug. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug
4. Mullard A. Landmark Alzheimer’s drug approval confounds research community. Nature (London). 2021;594:309-310. 
5. Salloway S, Chalkias S, Barkhof F, et al. Amyloid-related imaging abnormalities in 2 phase 3 studies evaluating aducanumab in patients with early Alzheimer disease. JAMA Neurol. 2022;79(1):13-21. doi:10.1001/jamaneurol.2021.4161
6. Prillaman M. Alzheimer’s drug slows mental decline in trial – but is it a breakthrough? Nature (London). 2022;610:15-16. 
7. Center for Drug Evaluation and Research. 2021. Aducanumab (marketed as Aduhelm) information. U.S. Food and Drug Administration. https://bit.ly/3TLajrj