Cognitive Safety is Largely Ignored in Clinical Drug Trials: A Study of Registered Study Protocols.

ABSTRACT:

Background and objective

The number of reports on suspected drug-induced memory impairment submitted to the US Food and Drug Administration increased 30-fold from 2000 to 2022. Drugs are the most common cause of reversible dementia. However, there is very little research on drug-induced cognitive impairment. The aim of this study was to investigate if and how an assessment of cognitive safety was included in recent, registered, controlled, clinical drug trials.

Methods

The clinical trials registry ( www.

Clinicaltrials

gov ) was searched for randomized controlled clinical trials with available study protocols. After excluding irrelevant trials such as surgical procedures, local or short-term treatment, and dietary supplements, 803 trials were included in this study. T

SUBMITTER: Reimers A 

PROVIDER: S-EPMC10764477 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature