Prodromal Alzheimer's DiseaseBITaNNCT04992975
Brain Iron Toxicity and Neurodegeneration - A 7T MRI Study
An observational study of Prodromal Alzheimer's Disease and Mild Cognitive Impairment, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prodromal Alzheimer's Disease, Mild Cognitive Impairment
- What is being tested?
- MRI at 7T
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Sep 2021to Mar 2025
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Alzheimer's Group: Preclinical or Prodromal Alzheimer's disease classified as either A+T-N- or A+T+N- Control Group: individual within 1.5 standard deviation of normal cognition in all tests
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Nottingham University Hospitals NHS Trust
Nottingham, East Midland, NG7 2UH
Hannah Sargisson, Hannah.Sargisson@nuh.nhs.uk
About this study
Official title: Brain Iron Toxicity and Neurodegeneration - An Ultrahigh Field (7T) MRI Study
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
Read the detailed description
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.
- Being tested
- MRI at 7T
- Keywords
- Ultrahigh Field MRI, 7T MRI, QSM
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI at 7TOther
MRI at 7T
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: MRI at 7T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Susceptibility Mapping, QSM (from 7T MRI data) to hippocampal subfield volume loss at 1 year
Relationship between QSM at recruitment and to hippocampal subfield volume (QSM and hippocampal subfield volume are obtained from 7T MRI Susceptibility Weighted and T1 Weighted images)
Measured: one year
Secondary outcomes (2)
cross-sectional and longitudinal changes in QSM in the hippocampal subfields
cross-sectional and longitudinal changes in QSM in the local hippocampal subfield QSM and volume loss after 1 year. QSM and hippocampal subfields volume will be obtained from 7T MRI data
Measured: one year
neuropsychological measures in relation to QSM and volume loss in hippocampal subfields
neuropsychological measures at 0 and 12 months in relation to QSM and volume loss in hippocampal subfields (adjusted for APOe). QSM and hippocampal subfield volume loss are obtained from 7T MRI Susceptibility Weighted and T1 Weighted images.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start10 Sep 2021
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prodromal Alzheimer's 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Akram Hosseini, Principal investigator, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992975
- Sponsor's protocol ID
- 19NS038
- Acronym
- BITaN
- Status last verified
- Feb 2024
- First submitted
- 21 Jul 2021
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38614372
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Iron Toxicity and Neurodegeneration - An Ultrahigh Field (7T) MRI Study
- ClinicalTrials.gov ID
- NCT04992975
- Acronym / sponsor ID
- BITaN / 19NS038
- Keywords
- Ultrahigh Field MRI, 7T MRI, QSM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 6 Aug 2021 (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.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's disease | – | Other: MRI at 7TPatients 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. |
| Control group | – | Other: MRI at 7TAge 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Alzheimer's Group: Preclinical or Prodromal Alzheimer's disease classified as either A+T-N- or A+T+N- Control Group: individual within 1.5 standard deviation of normal cognition in all tests
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (7 listed)
- Lack of mental capacity to consent to study involvement
- Not speaking English before age 5 years
- Learning disability
- Schizophrenia
- Substance misuse
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 |
|---|---|---|
| MRI at 7TMRI at 7T | Other | Alzheimer's disease, Control group |
Primary outcome
Quantitative Susceptibility Mapping, QSM (from 7T MRI data) to hippocampal subfield volume loss at 1 year
Time frame: one year
Relationship between QSM at recruitment and to hippocampal subfield volume (QSM and hippocampal subfield volume are obtained from 7T MRI Susceptibility Weighted and T1 Weighted images)
2 secondary outcomes
cross-sectional and longitudinal changes in QSM in the hippocampal subfields
Time frame: one year
neuropsychological measures in relation to QSM and volume loss in hippocampal subfields
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Derived from this study: PubMed 38614372Hari 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.
- Individual participant dataSharing planned: No
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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.
Akram Hosseini principal investigator
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prodromal Alzheimer's Disease and Mild Cognitive Impairment, run by Nottingham University Hospitals NHS Trust 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rebecca Boulton (01159249924, Rebecca.Boulton@nuh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Susceptibility Mapping, QSM (from 7T MRI data) to hippocampal subfield volume loss at 1 year (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04992975, which also lists 1 linked publication.
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 21 Mar 2024.