Clinical trial NCT05220150: Discovering FFC-MRI Biomarkers of Alzheimer Disease
Official title: Non-invasive In-vivo Characterisation of Alzheimer's Disease Using Fast-field Cycling Magnetic Resonance Imaging (FFC MRI)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open labelled feasibility study with a control group.
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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)

Eligibility criteria: 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

Primary outcomes:
measure: Primary Outcome
timeFrame: 12 weeks
Secondary outcomes:
measure: Secondary Outcome
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Biomedical Physics Building, Foresterhill Health Campus
state: Scotland
Study officials:
References: