IJCEMR

Article http://dx.doi.org/10.26855/ijcemr.2025.11.005

Dose Escalation Strategy and Safety Observation of Neurogenesis-regulating Drugs in Phase I Clinical Trials for Alzheimer’s Disease

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Qingyu Bai

Shenzhen MSU-BlT University, Shenzhen 518172, Guangdong, China.

*Corresponding author: Qingyu Bai

Published: November 27,2025

Abstract

Developing Phase I trials for Alzheimer’s therapeutics that target neurogenesis requires customized approaches to dosing and safety. This research addresses the challenge by proposing a unified framework built on model-informed design, dynamic biomarker assessment, and specialized evaluation of central nervous system safety. Insights from clinical data analysis are applied to key methodological considerations, including the determination of a first-in-human dose, PK/PD model-driven optimization of subsequent doses, and safety protocols that integrate neurophysiological surveillance with the management of potential long-term carcinogenic effects. The objective is to provide a methodological guide for advancing such innovative drugs through early-stage clinical testing.

Keywords

Alzheimer’s disease; dose escalation; pharmacokinetics; pharmacodynamics

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How to cite this paper

Dose Escalation Strategy and Safety Observation of Neurogenesis-regulating Drugs in Phase I Clinical Trials for Alzheimer’s Disease

How to cite this paper: Qingyu Bai. (2025) Dose Escalation Strategy and Safety Observation of Neurogenesis-regulating Drugs in Phase I Clinical Trials for Alzheimer’s Disease. International Journal of Clinical and Experimental Medicine Research, 9(6), 614-618.

DOI: http://dx.doi.org/10.26855/ijcemr.2025.11.005