MedDataX Logo

Volumetric Magnetic Resonance Imaging in Dementia

NCT ID: NCT05119114

Last Updated: 2021-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-31

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Dementia Alzheimer Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with any type of dementia.
* Patients with mini mental state examination equal or more than 18.

Exclusion Criteria

* Patients with contra-indications to MRI.
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Abdel-Tawab Mohamed

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hosam A Youssif, MD

Role: STUDY_DIRECTOR

Assiut University

Ahmed Abdel-Razzak, McS

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assiut University

Asyut, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ahmed Abdel-Razzak, McS

Role: CONTACT

Phone: 01147160733

Email: [email protected]

Mohamed Abdeltawab, MD

Role: CONTACT

Phone: +201009319309

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 16360788 (View on PubMed)

Fennema-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.

Reference Type RESULT
PMID: 19277975 (View on PubMed)

Duchesne 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.

Reference Type RESULT
PMID: 18390347 (View on PubMed)

Ten 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.

Reference Type RESULT
PMID: 28317647 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MRI in dementia

Identifier Type: -

Identifier Source: org_study_id