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

NHS Trust

Status: Enrolling

Conditions: Prodromal Alzheimer's Disease; Mild Cognitive Impairment

Treatments: Other: MRI at 7T

Study type: Observational

Funder types: Other

Identifiers

NCT04992975

19NS038

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Alzheimer's disease

Description:

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.

Treatment:

Other: MRI at 7T

Control group

Description:

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.

Treatment:

Other: MRI at 7T