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

NCT06250842 | Recruiting

• 1 other identifier: PJ-KS-KY-2023-577
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Benzodiazepine Adverse Reaction; Depression, Anxiety; Benzodiazepine Dependence

Keywords

Benzodiazepines; Long Term Adverse Effects; Cognitive Neuroscience; Neuroendocrinology; immunomodulatory potential

Outcome Measures

Primary Outcomes (2)

• Brain hemodynamic activity with fNIRS

  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.

  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)

  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.

  for 3 years

Secondary Outcomes (4)

• Mini-Mental State Evaluation (MMSE)

  About 15 min during the study visit

• Scores of Hamilton Depression Scale

  About 15 min during the study visit

• Scores of Hamilton Anxiety Scale

  About 15 min during the study visit

• Pittsburgh Sleep Quality Index

  About 15 min during the study visit

Study Arms (3)

Long-term benzodiazepine use group

Continuous use of benzodiazepines for ≥3 months

Non-benzodiazepine use group

No history of prior benzodiazepine use

Healthy Controls

Healthy Controls

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The First Affiliated Hospital of Dalian Medical University

You may qualify if:

• Continuous use of benzodiazepines for ≥3 months, matched with participants who have not taken benzodiazepines.
• Education time ≥6 years.
• Abstained from alcohol, coffee, and other psychoactive substances in the 24 hours before the examination.

You may not qualify if:

• Brain damage due to various reasons (such as head trauma, dementia, epilepsy, brain tumors, etc.).
• Severe systemic diseases (such as malignant tumors, etc.).
• Acute cerebrovascular disease in the past 3 months. History of substance abuse other than benzodiazepines (such as alcohol, opioids, etc.).
• Inability to cooperate with fNIRS, PET/MRI examinations, and scale assessments.

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116000, China

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders; Long Term Adverse Effects

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hui min Zhang

  The First Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui min Zhang

CONTACT

+86 18098876233; huiminzhangxs@163.com

Mei chen Liu

CONTACT

+86 18098871637; meichenliu9019@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 9, 2024
• Study Start: February 11, 2024
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 11, 2025

Record last verified: 2025-02

Locations

CN (1)