NCT06250842 Benzodiazepine Impact on Cognitive Function: fNIRs and PET/MRI Study
| NCT ID | NCT06250842 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital of Dalian Medical University |
| Condition | Benzodiazepine Adverse Reaction |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-02-11 |
| Primary Completion | 2027-02-20 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
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.