NCT05119114

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 12, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 12, 2021

Status Verified

November 1, 2021

Enrollment Period

1.9 years

First QC Date

October 18, 2021

Last Update Submit

November 10, 2021

Conditions

DementiaAlzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • MRI Accuracy in dementia

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

    1 week

Interventions

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.

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patients with contra-indications to MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 16360788RESULT

  • 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.

    PMID: 19277975RESULT

  • 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.

    PMID: 18390347RESULT

  • 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.

    PMID: 28317647RESULT

MeSH Terms

Conditions

DementiaAlzheimer Disease

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Hosam A Youssif, MD

    Assiut University

    STUDY DIRECTOR

  • Ahmed Abdel-Razzak, McS

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Abdel-Razzak, McS

CONTACT

01147160733Ahmedabdelrazzak90@gmail.com

Mohamed Abdeltawab, MD

CONTACT

+201009319309dr.m.tawab@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 18, 2021

First Posted

November 12, 2021

Study Start

December 1, 2021

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

November 12, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)