NCT05220150

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2017

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
Last Updated

February 2, 2022

Status Verified

February 1, 2022

Enrollment Period

3.9 years

First QC Date

December 2, 2020

Last Update Submit

February 1, 2022

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome

    The FFC-MRI T1 maps of patients and controls, with SPECT findings for validation. The outcome used for the primary research question will be the statistical significance in the difference of image contrast between the control group and the patient group. The presence of AD in the patient group will be estimated using the current clinical standard, cognitive testing with MoCA) or MMSE and blood flow SPECT CT imaging. If the participant has recently had an MRI scan using 3T MRI, we will ask for permission from the participant to access these images and use them for comparison. The level of significance of the differences will be derived using the statistical test most adapted to the contrast, depending on the distribution profile across the samples. No previous data exist to guide our choice.

    12 weeks

Secondary Outcomes (1)

  • Secondary Outcome

    12 weeks

Study Arms (2)

Alzheimer's patients

EXPERIMENTAL

Patient diagnosed with early onset Alzheimer's disease.

Device: FFC-MRI scan

Control

ACTIVE COMPARATOR

Healthy volunteers that do not have Alzheimer's disease.

Device: FFC-MRI scan

Interventions

FFC-MRI scanDEVICE

Undergo one FFC-MRI scan.

Alzheimer's patientsControl

Eligibility Criteria

Age21 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomedical Physics Building, Foresterhill Health Campus

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Open labelled feasibility study with a control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2020

First Posted

February 2, 2022

Study Start

October 17, 2017

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

February 2, 2022

Record last verified: 2022-02

Locations

GB(1)