Brain Iron Toxicity and Neurodegeneration - A 7T MRI Study

Mild Cognitive Impairment Clinical Trial

— BITaN  

Official title:

Brain Iron Toxicity and Neurodegeneration - An Ultrahigh Field (7T) MRI Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04992975
• Other study ID #: 19NS038
• Status: Recruiting
• Start date: September 10, 2021
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Nottingham University Hospitals NHS Trust
• Contact: rebecca Boulton
• Phone: 01159249924
• Email: Rebecca.Boulton[@]nuh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A longitudinal observational neuroimaging study of individuals with Early Onset Alzheimer's disease during the prodromal phase, and matched control group - Ultrahigh Field MRI study at 7T

Description:

This study aims to determine whether high resolution MRI at 7T and Quantitative Susceptibility Mapping (QSM) can demonstrate a specific pattern of iron overload in strategically important areas of brain as a sensitive marker of pathological Alzheimer's disease i.e. patients with subjective or mild cognitive impairment associated with Amyloid or tau pathological state in the cerebrospinal fluid.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Ability to provide informed consent

• Patients with pathological diagnosis of Alzheimer's disease according to the National Institute on Aging and Alzheimer's Association, NIA-AA, criteria (Alzheimer's group) or cognitively normal individuals within 1.5 standard deviation of normal in all tests (control group)

Exclusion Criteria:

• Lack of mental capacity to consent to study involvement

• Not speaking English before age 5 years

• Learning disability

• Schizophrenia

• Substance misuse

• Implanted devices not certified as compatible with ultra-high field MRI (e.g. cardiac pacemaker)

• Pregnancy

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment
• Nerve Degeneration
• Prodromal Alzheimer's Disease

Intervention

Other:
• MRI at 7T
MRI at 7T

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham	East Midland

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative Susceptibility Mapping, QSM (from 7T MRI data) to hippocampal subfield volume loss at 1 year	Relationship between QSM at recruitment and to hippocampal subfield volume (QSM and hippocampal subfield volume are obtained from 7T MRI Susceptibility Weighted and T1 Weighted images)	one year
Secondary	cross-sectional and longitudinal changes in QSM in the hippocampal subfields	cross-sectional and longitudinal changes in QSM in the local hippocampal subfield QSM and volume loss after 1 year. QSM and hippocampal subfields volume will be obtained from 7T MRI data	one year
Secondary	neuropsychological measures in relation to QSM and volume loss in hippocampal subfields	neuropsychological measures at 0 and 12 months in relation to QSM and volume loss in hippocampal subfields (adjusted for APOe). QSM and hippocampal subfield volume loss are obtained from 7T MRI Susceptibility Weighted and T1 Weighted images.	one year