The Clinical Trials Landscape for Alzheimer's Disease

Area of Science:

• Neurology
• Clinical Trials
• Biomedical Research

Background:

• The scope of Alzheimer's disease (AD) clinical trials, encompassing drug, non-drug, and non-therapeutic research, remains incompletely understood.
• Characterizing the landscape of AD research is crucial for identifying trends and future directions.

Purpose of the Study:

• To comprehensively analyze the trends and focus areas of clinical studies in Alzheimer's disease over the past two decades.
• To map the evolution of drug development, non-drug interventions, and non-therapeutic research in AD.

Main Methods:

• Analysis of 1681 AD clinical trials registered in clinicaltrials.gov.
• Bibliometric network analysis of 565 associated publications in PubMed.
• Categorization of research objectives and interventions, including drug classes, non-drug therapies, and non-therapeutic research areas.

Main Results:

• Frequent keywords in publications include "safety," "dose," "adverse events," and "biomarker."
• Top drug classes target amyloid, acetylcholine, or neurotransmitter receptors.
• Leading non-drug therapies are physical therapy, diet, and cognitive training; non-therapeutic research focuses on imaging, risk factors, and biomarkers.
• Significant upward trends were observed in prevention, risk factors, and microbiome research (P_trend < 0.05).

Conclusions:

• Recent successes like lecanemab and decanemab validate ongoing efforts in AD drug development and pathogenesis research.
• The increasing focus on non-drug interventions and non-therapeutic research, particularly in prevention and microbiome studies, suggests promising future avenues for AD management and treatment.