CClinicalTrials.gg
Status unknownNCT05119114Updated Nov 12, 2021

Volumetric Magnetic Resonance Imaging in Dementia

An observational study in Dementia and Alzheimer Disease, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 60 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-11-12.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
60 Years to 90 Years
Sex
All
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Study 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. 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

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Conditions studied

  • Dementia
  • Alzheimer Disease
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In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 40 is below the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with contra-indications to MRI.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testMagnetic 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.

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What researchers measure

Primary outcomes

  1. MRI Accuracy in dementia

    Assess the accuracy of magnetic resonance imaging in differentiate between normal aging and cases of dementia

    Time frame: 1 week

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Study locations

1 site
  • Assiut University
    Assiut, 71515, Egypt
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References and documents

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 16360788 ↗
  • 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. PubMed 19277975 ↗
  • 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. PubMed 18390347 ↗
  • 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. PubMed 28317647 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05119114
Lead sponsor
Assiut University
Responsible party
Mohamed Abdel-Tawab Mohamed (Dr, Assiut University) — Principal investigator
First posted
Nov 12, 2021
Start date
Dec 2021 (estimated)
Primary completion
Nov 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Nov 12, 2021

Study contacts

Ahmed Abdel-Razzak, McS
Contact
Ahmedabdelrazzak90@gmail.com
01147160733 ext. +20
Mohamed Abdeltawab, MD
Contact
dr.m.tawab@gmail.com
+201009319309
Hosam A Youssif, MD
study director · Assiut University
Ahmed Abdel-Razzak, McS
principal investigator · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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