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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05545657
Other study ID # 2022-LCYJ-MS-03
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 18, 2022
Est. completion date August 31, 2025

Study information

Verified date August 2022
Source The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Contact Bing Zhang, MD, PhD
Phone 86-15851803070
Email zhangbing_nanjing@vip.163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a cross-sectional and longitudinal study to investigate the relationship and central mechanism between type 2 diabetes and cognitive impairment based on the simultaneous EEG-fMRI approach and peripheral neuropathology biomarkers assay.


Description:

Little is known about the high risks of cognitive impairment and Alzheimer's Disease (AD) in people with type 2 diabetes. The goal of this study is to characterize brain imaging biomarkers of preclinical AD and related cognitive impairment in people with type 2 diabetes using the simultaneous EEG-fMRI approach and peripheral neuropathology biomarkers assay. We will recruit 400 patients with type 2 diabetes in the outpatient and inpatient departments. Each subject will undergo simultaneous EEG-fMRI scan, classical multimodal MRI scan, cognitive assessments and peripheral neuropathology biomarkers assay at the baseline. This study will qualify gray matter volume, cortical thickness, gray matter and white matter microstructure, cerebral blood flow, spectrum changes, as well as resting state and dynamic functional network connectivity from the imaging examination. Study duration was 3 years with a follow-up every 12 months. Cognitive assessments and imaging scan will be conducted in each follow-up visits. At the end of the study, all of the assessments will be performed again for all recruited subjects.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date August 31, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria: - Aged 40-75 years - Right handedness - Possessed over 6-year education - Provision of informed consent prior to any study specific procedures Exclusion Criteria: - Control participants would be excluded if they had a fasting blood glucose level >7.0 mmol/L; glucose level> 7.8 mmol/L after oral glucose tolerance test (OGTT); HbA1c>5.7% - Control participants would be excluded if they had a Montreal Cognitive Assessment (MoCA, Beijing edition) score of < 26 - History of other dementia-related neurological or psychiatric disorders, including psychotic developmental disorders, mania, depression, and schizophrenia - Central neural system diseases, including traumatic brain injury, intracranial hemorrhage, and acute cerebral infarction - Acute complications of diabetes, including diabetic ketoacidosis, hyperglycemic hyperosmolar state, and hypoglycemic coma - Complicated with severe impairment of liver, kidney or heart function - Metal implants, unable to complete the MR scanning - Pregnant or lactating women

Study Design


Intervention

Behavioral:
Cognitive assessments
Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Rey Auditory Verbal Learning Test (RAVLT), Boston Naming Test (BNT), Digit Span Test (DST), Trail Making Test (TMT).
Other:
Simultaneous EEG-fMRI scan
EEG recordings were conducted with a 64-channel MR-compatible EEG system (Electrical Geodesics Inc., Eugene, OR, USA) and an MR-compatible EEG cap (HydroCel Geodesic Sensor Nets), using ring-type sintered silver chloride electrodes with iron-free copper leads.
Multimodal magnetic resonance imaging
3D T1-weighted imaging, Resting-state fMRI, Diffusion tensor imaging, Arterial spin labeling.
Peripheral blood neuropathology biomarkers assay
Detecting the peripheral blood neuropathology biomarkers using single molecule array (Simoa) technique, including Aß40, Aß42, P-tau 181, P-tau 231, GFAP and NfL.

Locations

Country Name City State
China Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Baseline cognitive performance The Montreal Cognitive Assessment (MoCA) score, ranges from 0 to 30, and higher scores mean better cognition. Day 1 of entry study
Primary Baseline peripheral blood neuropathology biomarkers level Aß40, Aß42, P-tau 181, P-tau 231, GFAP and NfL. Blood samples will be collected on day 1 of the entry study and preserved at -81 °C in the Biobank of Drum Tower Hospital until examination.
Primary Baseline simultaneous EEG-fMRI Frequency domain and spectrum domain analyses Within 1 week after cognitive assessments
Primary Baseline brain structural MRI scan Cortical morphology Within 1 week after cognitive assessments
Primary Baseline brain functional MRI scan Large-scale network functional connectivity Within 1 week after cognitive assessments
Secondary Longitudinal changes of cognitive performance Compare the change of MoCA score from baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months). From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).
Secondary Longitudinal changes of peripheral blood neuropathology biomarkers level Compare the changes of peripheral blood neuropathology biomarkers level from baseline to final follow-up time points (36 months). From baseline to final follow-up time points (36 months).
Secondary Longitudinal changes of simultaneous EEG-fMRI Compare the change of frequency domain and spectrum domain from baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months). From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).
Secondary Longitudinal changes of brain structural MRI scan Compare the changes of cortical morphology from baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months). From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).
Secondary Longitudinal changes of brain functional MRI scan Compare the changes of large-scale network functional connectivity from baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months). From baseline to each follow-up time points (6 months, 12 months, 18 months, 24 months, 30months, 36 months).
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