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NCT06250842

Benzodiazepine Impact on Cognitive Function: fNIRs and PET/MRI Study

Recruiting now Last updated 11 April 2025
What this trial tests

trial in Benzodiazepine Adverse Reaction in 100 participants. Currently enrolling.

Timeline
11 February 2024
Primary endpoint
20 February 2027
30 June 2027

Quick facts

Lead sponsorThe First Affiliated Hospital of Dalian Medical University
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment100
Start date11 February 2024
Primary completion20 February 2027
Estimated completion30 June 2027
Sites1 location across China

Conditions studied

Sponsor

The First Affiliated Hospital of Dalian Medical University

Who can join

Adults 18 to 80, any sex, with Benzodiazepine Adverse Reaction or Depression, Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study explores the impact of long-term benzodiazepine (BZDs) use on cognitive function and associated neuroimaging markers. While BZDs are established treatments for conditions like anxiety and insomnia, recent warnings highlight risks, including neurocognitive effects. Neuroimaging studies indicate potential neuroprotective effects of BZDs. Functional near-infrared spectroscopy (fNIRS) measures cerebral cortex function during cognitive tasks. Combining fNIRS with mood and cognitive scales, this study assesses cortical activation. 2-deoxy-2-fluoro-D-glucose-positron emission tomography (FDG-PET) evaluates brain metabolism. DPA-714 PET assesses neuroinflammation. The primary objective is to compare brain functional activation, metabolism, and neuroinflammatory levels between long-term BZD users and non-users. This comprehensive approach aims to provide insights into BZD effects on cognition and associated brain markers.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Enhanced interhemispheric functional connectivity in elderly anxiety patients with long-term benzodiazepine use: an fNIRS study.
    Chang Y, Liu M, Liu Y, Xie X, et al · · 2026 · PMID 41656398 · DOI 10.1038/s41598-026-39359-w

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