DementiaNCT05119114
Volumetric Magnetic Resonance Imaging in Dementia
An observational study of Dementia and Alzheimer Disease, run by Assiut University at 1 site in Egypt.
Trial summary
Dementia is a term for the impaired ability to remember, think, or make decisions that interferes with doing everyday activities. Alzheimer's disease is the most common type of dementia. Though dementia mostly affects older adults, it is not a part of normal aging. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Dementia, Alzheimer Disease
- What is being tested?
- Magnetic Resonance Imaging (MRI)
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2021to Dec 2023
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted over the period of 2 years during which all available cases with dementia presented to the Neurology Centre at Assiut university well be investigated.
Who may be able to join
- Patients with any type of dementia.
- Patients with mini mental state examination equal or more than 18.
Who cannot join
- Patients with contra-indications to MRI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Volumetric Magnetic Resonance Imaging in Evaluation of Different Types of Dementia
Dementia is a term for the impaired ability to remember, think, or make decisions that interferes with doing everyday activities. Alzheimer's disease is the most common type of dementia. Though dementia mostly affects older adults, it is not a part of normal aging. This study aims to assess the role of volumetric MRI in evaluation of different types of dementia.
Read the detailed description
Neurocognitive disorders (dementia) are prevalent clinical problems. With the increase in average life expectancy, its prevalence is rising at an alarming rate. In 2005, an estimated 24 million people around the world suffered from dementia, and that number is expected to double every 20 years. By 2040, it is predicted that over 81 million people worldwide will suffer from dementia. Most experts agree that treatment will be most beneficial if applied early, before significant, potentially irreversible neurodegeneration and functional impairment has occurred.
Clinical symptoms of most subtypes of dementia arise from progressive neuron and synapse loss, with the resulting tissue atrophy. Brain magnetic resonance imaging (MRI) is regularly used in diagnosing dementia as it visualises the structural changes caused by neurodegeneration. It is key in defining subtle differences between healthy and pathological cerebral volume loss and between dementia subtypes.
Visual assessment of brain atrophy patterns is commonly supported through the use of visual rating scales. However, these scales have a subjective element and their application relies heavily on the prior experience of the radiologist using them. And they have poor sensitivity to subtle or prodromal changes and have ceiling and/or floor effects.
Application of quantitative volumetric reporting tools, which automatically quantify an individual patient's regional brain volumes and compare them to healthy populations, can potentially help in interpretation of the severity and distribution of brain atrophy and contextualize their findings by referencing normative brain volumes in healthy populations. This will improve the accuracy of radiological diagnosis of different subtypes of dementia
- Conditions
- Dementia, Alzheimer Disease
- Being tested
- Magnetic Resonance Imaging (MRI)
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Diagnostic test
A standardized multi-parametric MRI protocol will be implemented for all patients. All sequences will be acquired on a 1.5 Tesla scanner. After completion of the MRI study, the digital imaging and communication data will be sent to a diagnostic workstation for post-processing and analysis. Patients of the study will be subjected to detailed structural MRI for detection of signs of neurodegenerative changes. Volumetric high-resolution 3D scans will be used for quantitative study.
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI Accuracy in dementia
Assess the accuracy of magnetic resonance imaging in differentiate between normal aging and cases of dementia
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study startDec 2021 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdel-Tawab Mohamed, Assiut University
- Investigators
- Hosam A Youssif, MD, Study director, Assiut UniversityAhmed Abdel-Razzak, McS, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119114
- Sponsor's protocol ID
- MRI in dementia
- Status last verified
- Nov 2021
- First submitted
- 18 Oct 2021
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferri CP, Prince M, Brayne C, Brodaty H, Fratiglioni L, Ganguli M, Hall K, Hasegawa K, Hendrie H, Huang Y, Jorm A, Mathers C, Menezes PR, Rimmer E, Scazufca M; Alzheimer's Disease International. Global prevalence of dementia: a Delphi consensus study. Lancet. 2005 Dec 17;366(9503):2112-7. doi: 10.1016/S0140-6736(05)67889-0.
PubMed 16360788Fennema-Notestine C, Hagler DJ Jr, McEvoy LK, Fleisher AS, Wu EH, Karow DS, Dale AM; Alzheimer's Disease Neuroimaging Initiative. Structural MRI biomarkers for preclinical and mild Alzheimer's disease. Hum Brain Mapp. 2009 Oct;30(10):3238-53. doi: 10.1002/hbm.20744.
PubMed 19277975Duchesne S, Caroli A, Geroldi C, Barillot C, Frisoni GB, Collins DL. MRI-based automated computer classification of probable AD versus normal controls. IEEE Trans Med Imaging. 2008 Apr;27(4):509-20. doi: 10.1109/TMI.2007.908685.
PubMed 18390347Ten Kate M, Barkhof F, Boccardi M, Visser PJ, Jack CR Jr, Lovblad KO, Frisoni GB, Scheltens P; Geneva Task Force for the Roadmap of Alzheimer's Biomarkers. Clinical validity of medial temporal atrophy as a biomarker for Alzheimer's disease in the context of a structured 5-phase development framework. Neurobiol Aging. 2017 Apr;52:167-182.e1. doi: 10.1016/j.neurobiolaging.2016.05.024.
PubMed 28317647
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Volumetric Magnetic Resonance Imaging in Evaluation of Different Types of Dementia
- ClinicalTrials.gov ID
- NCT05119114
- Acronym / sponsor ID
- MRI in dementia
- Conditions
- Dementia, Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 12 Nov 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.
Dementia is a term for the impaired ability to remember, think, or make decisions that interferes with doing everyday activities. Alzheimer's disease is the most common type of dementia. Though dementia mostly affects older adults, it is not a part of normal aging. This study aims to assess the role of volumetric MRI in evaluation of different types of dementia.
Detailed description
Neurocognitive disorders (dementia) are prevalent clinical problems. With the increase in average life expectancy, its prevalence is rising at an alarming rate. In 2005, an estimated 24 million people around the world suffered from dementia, and that number is expected to double every 20 years. By 2040, it is predicted that over 81 million people worldwide will suffer from dementia. Most experts agree that treatment will be most beneficial if applied early, before significant, potentially irreversible neurodegeneration and functional impairment has occurred.
Clinical symptoms of most subtypes of dementia arise from progressive neuron and synapse loss, with the resulting tissue atrophy. Brain magnetic resonance imaging (MRI) is regularly used in diagnosing dementia as it visualises the structural changes caused by neurodegeneration. It is key in defining subtle differences between healthy and pathological cerebral volume loss and between dementia subtypes.
Visual assessment of brain atrophy patterns is commonly supported through the use of visual rating scales. However, these scales have a subjective element and their application relies heavily on the prior experience of the radiologist using them. And they have poor sensitivity to subtle or prodromal changes and have ceiling and/or floor effects.
Application of quantitative volumetric reporting tools, which automatically quantify an individual patient's regional brain volumes and compare them to healthy populations, can potentially help in interpretation of the severity and distribution of brain atrophy and contextualize their findings by referencing normative brain volumes in healthy populations. This will improve the accuracy of radiological diagnosis of different subtypes of dementia
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted over the period of 2 years during which all available cases with dementia presented to the Neurology Centre at Assiut university well be investigated.
Key inclusion criteria (2 listed)
- Patients with any type of dementia.
- Patients with mini mental state examination equal or more than 18.
Key exclusion criteria (1 listed)
- Patients with contra-indications to MRI.
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 |
|---|---|---|
| Magnetic Resonance Imaging (MRI)A standardized multi-parametric MRI protocol will be implemented for all patients. All sequences will be acquired on a 1.5 Tesla scanner. After completion of the MRI study, the digital imaging and communication data will be sent to a diagnostic workstation for post-processing and analysis. Patients of the study will be subjected to detailed structural MRI for detection of signs of neurodegenerative changes. Volumetric high-resolution 3D scans will be used for quantitative study. | Diagnostic test | – |
Primary outcome
MRI Accuracy in dementia
Time frame: 1 week
Assess the accuracy of magnetic resonance imaging in differentiate between normal aging and cases of dementia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- Results publication: PubMed 16360788Ferri CP, Prince M, Brayne C, Brodaty H, Fratiglioni L, Ganguli M, Hall K, Hasegawa K, Hendrie H, Huang Y, Jorm A, Mathers C, Menezes PR, Rimmer E, Scazufca M; Alzheimer's Disease International. Global prevalence of dementia: a Delphi consensus study. Lancet. 2005 Dec 17;366(9503):2112-7. doi: 10.1016/S0140-6736(05)67889-0.
- Results publication: PubMed 19277975Fennema-Notestine C, Hagler DJ Jr, McEvoy LK, Fleisher AS, Wu EH, Karow DS, Dale AM; Alzheimer's Disease Neuroimaging Initiative. Structural MRI biomarkers for preclinical and mild Alzheimer's disease. Hum Brain Mapp. 2009 Oct;30(10):3238-53. doi: 10.1002/hbm.20744.
- Results publication: PubMed 18390347Duchesne S, Caroli A, Geroldi C, Barillot C, Frisoni GB, Collins DL. MRI-based automated computer classification of probable AD versus normal controls. IEEE Trans Med Imaging. 2008 Apr;27(4):509-20. doi: 10.1109/TMI.2007.908685.
- Results publication: PubMed 28317647Ten Kate M, Barkhof F, Boccardi M, Visser PJ, Jack CR Jr, Lovblad KO, Frisoni GB, Scheltens P; Geneva Task Force for the Roadmap of Alzheimer's Biomarkers. Clinical validity of medial temporal atrophy as a biomarker for Alzheimer's disease in the context of a structured 5-phase development framework. Neurobiol Aging. 2017 Apr;52:167-182.e1. doi: 10.1016/j.neurobiolaging.2016.05.024.
- 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.
Hosam A Youssif, MD study director
Assiut University
Ahmed Abdel-Razzak, McS principal investigator
Assiut University
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 Dementia and Alzheimer Disease, run by Assiut University at 1 site in Egypt.
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 1 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 12 Nov 2021. 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 Egypt. 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 Ahmed Abdel-Razzak, McS (01147160733 ext. +20, Ahmedabdelrazzak90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI Accuracy in dementia (time frame: 1 week). 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 NCT05119114, which also lists 4 linked publications.
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 12 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.