Alzheimer DiseaseNCT05220150
Discovering FFC-MRI Biomarkers of Alzheimer Disease
A study testing FFC-MRI scan in people with Alzheimer Disease, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- FFC-MRI scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Oct 2017to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Biomedical Physics Building, Foresterhill Health Campus
Aberdeen, Scotland, AB25 2ZN
About this study
Official title: Non-invasive In-vivo Characterisation of Alzheimer's Disease Using Fast-field Cycling Magnetic Resonance Imaging (FFC MRI)
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.
Read the 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)
- Conditions
- Alzheimer Disease
- Being tested
- FFC-MRI scan
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFC-MRI scanDevice
Undergo one FFC-MRI scan.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's patients | Experimental | Patient diagnosed with early onset Alzheimer's disease. Receives: Device: FFC-MRI scan |
| Control | Active comparator | Healthy volunteers that do not have Alzheimer's disease. Receives: Device: FFC-MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Secondary Outcome
Variations in the FFC-MRI biomarkers obtained for the T1 maps. The outcome of interest to fulfil our secondary objective is the estimation of the distribution of the contrast identified as potential biomarkers. This will allow us to estimate the sample size for further validation studies.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start17 Oct 2017
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Why it stopped: Poor recruitment and poor scan image quality
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open labelled feasibility study with a control group.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220150
- Sponsor's protocol ID
- 2-031-16
- Status last verified
- Feb 2022
- First submitted
- 2 Dec 2020
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive In-vivo Characterisation of Alzheimer's Disease Using Fast-field Cycling Magnetic Resonance Imaging (FFC MRI)
- ClinicalTrials.gov ID
- NCT05220150
- Acronym / sponsor ID
- 2-031-16
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment and poor scan image quality
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open labelled feasibility study with a control group.
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's patients | Experimental | Device: FFC-MRI scanPatient diagnosed with early onset Alzheimer's disease. |
| Control | Active comparator | Device: FFC-MRI scanHealthy volunteers that do not have Alzheimer's disease. |
Who may qualify
- Ages
- 21 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FFC-MRI scanUndergo one FFC-MRI scan. | Device | Alzheimer's patients, Control |
Primary outcome
Primary Outcome
Time frame: 12 weeks
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.
1 secondary outcome
Secondary Outcome
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Poor recruitment and poor scan image quality). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FFC-MRI scan in people with Alzheimer Disease, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment and poor scan image quality). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.