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Clinical Trials in China / NCT06250842
Recruiting Observational

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

NCT06250842 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital of Dalian Medical University
Phase
Observational
Started
2024-02-11
Last updated
2025-04-11

Condition(s) studied

Benzodiazepine Adverse ReactionDepression, AnxietyBenzodiazepine Dependence

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Brain hemodynamic activity with fNIRS — for 3 years
    This includes changes in the concentration of oxygenated and deoxygenated hemoglobin as measured by the change in light absorption, along with comprehensive analyses of activation values and functional connectivity.
  • 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
    Estimates of brain TSPO concentrations measured with PET will serve as a marker for neuroinflammation. Variation of the regional cerebral glucose consumption and TSPO-PET measures, derived from neuroimaging (including structural, functional, and multimodal MRI), will be compared between three groups.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Dalian Medical University Dalian Liaoning Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06250842 on ClinicalTrials.gov ↗ ← All trials in China