Discovering FFC-MRI Biomarkers of Alzheimer Disease

NCT ID: NCT05220150

Last Updated: 2022-02-02

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

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-17

Study Completion Date

2021-09-01

Brief Summary

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Fast Field-Cycling MRI (FFC MRI) is a new scanning technology being developed at the University of Aberdeen. Previous pilot studies by the team on osteoarthritis, breast cancer, musculoskeletal cancer, liver fibrosis, thrombosis and muscle damage have demonstrated that FFC MRI provides useful information for clinical diagnostics in a variety of pathologies.

The aim of this study is to ascertain if brain imaging with FFC MRI yields any useful information in the diagnosis and evaluation of Alzheimer's disease.

Detailed Description

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Alzheimer's disease (AD) patients and appropriate controls will be identified by consultants working with the patient group.

Potential participants will be approached by letter by their clinician. The purpose of this study will be explained to them and they will be asked for signed informed consent.

Communication between the clinical team and FFC-MRI research team will ensure that any appointment for FFC-MRI is made at a time that is convenient for the patient and clinical team.

The aim is to recruit 25 individuals with AD and 25 age matched controls.

FFC-MRI images will be acquired on dedicated equipment specifically built for the purpose of imaging human volunteers and patients. Where clinically appropriate patents will undergo other imaging procedures as part of their normal NHS care.

FFC-MRI will be compared standard clinical care data to identify regions of interest for quantitative analysis of FFC MRI data.

Anonymous personal information will be collected from the NHS patient records for stratification of the results (such as age, sex or relevant examination results)

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Open labelled feasibility study with a control group.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Alzheimer's patients

Patient diagnosed with early onset Alzheimer's disease.

Group Type EXPERIMENTAL

FFC-MRI scan

Intervention Type DEVICE

Undergo one FFC-MRI scan.

Control

Healthy volunteers that do not have Alzheimer's disease.

Group Type ACTIVE_COMPARATOR

FFC-MRI scan

Intervention Type DEVICE

Undergo one FFC-MRI scan.

Interventions

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FFC-MRI scan

Undergo one FFC-MRI scan.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with probable Alzheimer's disease, based upon cognitive testing (MMSE) and SPECT imaging.
* Controls will be participants without known cognitive impairment or Alzheimer's disease.
* Subjects capable of giving informed consent.
* Age 21 and above

Exclusion Criteria

* MRI-incompatible condition detected in the MR screening sheet such as some metallic implanted devices (see MR screening sheet in the project files).
* Claustrophobia
* Waist circumference larger than 102 cm, due to the limited bore size of the scanner.
* Restrictions to mobility such that patients are unable to be positioned in scanner by trained research radiographer e.g. severe kyphosis
* Cognitive impairment of sufficient severity that the participant does not have capacity to give informed consent
* Pregnancy
* Persons who might not adequately understand verbal explanations or written information given in English, or who have special communication needs
* Dementia of sufficient severity that the participant cannot give informed consent
Minimum Eligible Age

21 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aberdeen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Biomedical Physics Building, Foresterhill Health Campus

Aberdeen, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2-031-16

Identifier Type: -

Identifier Source: org_study_id

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