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

ClinicalTrials.gov IDNCT06250842

PhaseNot Applicable

Enrollment100

SponsorThe First Affiliated Hospital of Dalian Medical University

Age18 Years

SexALL

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Conditions studied

Benzodiazepine Adverse Reaction, Depression, Anxiety, Benzodiazepine Dependence

About this study

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.

Primary outcomes

Brain hemodynamic activity with fNIRS (for 3 years)
Longitudinal evolution of biomarkers measured from neuroimaging (including structural, functional, and multimodal MRI) and molecular neuroimaging (18F-FDG PET/MRI、DPA-714-PET/MRI) (for 3 years)

Eligibility information

Inclusion Criteria: 1. Continuous use of benzodiazepines for ≥3 months, matched with participants who have not taken benzodiazepines. 2. Education time ≥6 years. 3. Abstained from alcohol, coffee, and other psychoactive substances in the 24 hours before the examination. Exclusion Criteria： 1. Brain damage due to various reasons (such as head trauma, dementia, epilepsy, brain tumors, etc.). 2. Severe systemic diseases (such as malignant tumors, etc.). 3. Acute cerebrovascular disease in the past 3 months. History of substance abuse other than benzodiazepines (such as alcohol, opioids, etc.). 4. Inability to cooperate with fNIRS, PET/MRI examinations, and scale assessments.

Study locations

The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116000 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.