Brain Iron Toxicity and Neurodegeneration - A 7T MRI Study

NCT ID: NCT04992975

Last Updated: 2024-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-10

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Prodromal Alzheimer's Disease Mild Cognitive Impairment

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

MRI at 7T

Intervention Type OTHER

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.

MRI at 7T

Intervention Type OTHER

MRI at 7T

Interventions

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MRI at 7T

MRI at 7T

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Akram Hosseini

Role: PRINCIPAL_INVESTIGATOR

Nottingham University Hospitals NHS Trust

Locations

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Nottingham University Hospitals NHS Trust

Nottingham, East Midland, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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rebecca Boulton

Role: CONTACT

01159249924

Hannah Sargisson

Role: CONTACT

01159249924 ext. 84535

Facility Contacts

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Hannah Sargisson

Role: primary

References

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Hari I, Adeyemi OF, Gowland P, Bowtell R, Mougin O, Vesey P, Shah J, Mukaetova-Ladinska EB, Hosseini AA. Memory impairment in Amyloidbeta-status Alzheimer's disease is associated with a reduction in CA1 and dentate gyrus volume: In vivo MRI at 7T. Neuroimage. 2024 Apr 15;292:120607. doi: 10.1016/j.neuroimage.2024.120607. Epub 2024 Apr 12.

Reference Type DERIVED
PMID: 38614372 (View on PubMed)

Other Identifiers

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19NS038

Identifier Type: -

Identifier Source: org_study_id

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