Brain Iron Toxicity and Neurodegeneration - A 7T MRI Study (BITaN)

March 20, 2024 updated by: Nottingham University Hospitals NHS Trust

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Alzheimer's Group: Preclinical or Prodromal Alzheimer's disease classified as either A+T-N- or A+T+N- Control Group: individual within 1.5 standard deviation of normal cognition in all tests

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Alzheimer's disease

Patients with Early Onset Alzheimer's disease (with known cerebrospinal fluid Amyloid/tau status) during prodromal or mild phase will have MRI of the brain at 7T, neurocognitive assessments, and blood test to check APOe status.

Repeat neuroimaging and neurocognitive tests after one year.
Other: MRI at 7T
MRI at 7T
Control group

Age and gender matched individuals with normal cognition will have MRI of the brain at 7T, neurocognitive assessments and blood test to check APOe status.

Repeat neuroimaging, neurocognitive tests after one year.
Other: MRI at 7T
MRI at 7T

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative Susceptibility Mapping, QSM (from 7T MRI data) to hippocampal subfield volume loss at 1 year
Time Frame: one 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
cross-sectional and longitudinal changes in QSM in the hippocampal subfields
Time Frame: one year
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
neuropsychological measures in relation to QSM and volume loss in hippocampal subfields
Time Frame: one year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham University Hospitals NHS Trust

Investigators

  • Principal Investigator: Akram Hosseini, Nottingham University Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2021

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

July 21, 2021

First Submitted That Met QC Criteria

July 28, 2021

First Posted (Actual)

August 6, 2021

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19NS038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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