Clinical trials of new drugs for Alzheimer disease: a 2020–2023 update

• Published in: Journal of biomedical science Vol. 30; no. 1; pp. 1 - 19
• Main Authors: Huang, Li-Kai, Kuan, Yi-Chun, Lin, Ho-Wei, Hu, Chaur-Jong
• Format: Journal Article
• Language: English
• Published: Basel BioMed Central Ltd 02.10.2023; BioMed Central; BMC
• Subjects: Activities of daily living; Advertising executives; Alzheimer disease; Alzheimer's disease; Anti-amyloid; Anti-tau; Antibodies; Biomarkers; Brain damage; Brain injury; Brain research; Clinical trials; Cognitive enhancement; Dementia; Dementia disorders; Drug approval; Drug dosages; Drugs; FDA approval; Hypotheses; Inflammation; Medical research; Medicine, Experimental; Memory; Monoclonal antibodies; Neurodegenerative diseases; Neurons; Neuroprotection; Pathogenesis; Pathology; Pathophysiology; Product development; Proteins; Review; Tau protein; Trends; Viral antibodies; United States > US
• ISSN: 1423-0127; 1021-7770; 1423-0127
• DOI: 10.1186/s12929-023-00976-6

Alzheimer's disease (AD) is the leading cause of dementia, presenting a significant unmet medical need worldwide. The pathogenesis of AD involves various pathophysiological events, including the accumulation of amyloid and tau, neuro-inflammation, and neuronal injury. Clinical trials focusing on new drugs for AD were documented in 2020, but subsequent developments have emerged since then. Notably, the US-FDA has approved Aducanumab and Lecanemab, both antibodies targeting amyloid, marking the end of a nearly two-decade period without new AD drugs. In this comprehensive report, we review all trials listed in clinicaltrials.gov, elucidating their underlying mechanisms and study designs. Ongoing clinical trials are investigating numerous promising new drugs for AD. The main trends in these trials involve pathophysiology-based, disease-modifying therapies and the recruitment of participants in earlier stages of the disease. These trends underscore the significance of conducting fundamental research on pathophysiology, prevention, and intervention prior to the occurrence of brain damage caused by AD.