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Brain Iron Toxicity and Neurodegeneration - A 7T MRI Study

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04992975
Acronym
BITaN
Enrollment
40
Registered
2021-08-06
Start date
2021-09-10
Completion date
2025-03-31
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment, Prodromal Alzheimer's Disease

Keywords

Ultrahigh Field MRI, 7T MRI, QSM

Brief 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

Detailed 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.

Interventions

MRI at 7T

Sponsors

Nottingham University Hospitals NHS Trust
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Quantitative Susceptibility Mapping, QSM (from 7T MRI data) to hippocampal subfield volume loss at 1 yearone yearRelationship 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)

Secondary

MeasureTime frameDescription
cross-sectional and longitudinal changes in QSM in the hippocampal subfieldsone yearcross-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
neuropsychological measures in relation to QSM and volume loss in hippocampal subfieldsone yearneuropsychological 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.

Countries

United Kingdom

Contacts

Primary Contactrebecca Boulton
Rebecca.Boulton@nuh.nhs.uk01159249924
Backup ContactHannah Sargisson
Hannah.Sargisson@nuh.nhs.uk01159249924

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026