NCT05781139

Brief Summary

Dementia is a neurological disease that causes cognitive and behavioral impairments that could ultimately interfere with the ability to function at work or to do the usual daily activities. It is recognized as a healthcare and social burden and remains challenging in terms of proper diagnosis and treatment.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 20, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

March 10, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2026

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

2.4 years

First QC Date

February 20, 2023

Last Update Submit

March 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • detect difference between multiple types of dementia (Alzheimer's disease with early onset, and late-onset as well as multi-infarct dementia )

    detect difference between multiple types of dementia (Alzheimer's disease with early onset, and late-onset as well as multi-infarct dementia ) regarding clinical profile, biomarkers, and cortical excitability

    2 years

Study Arms (4)

Early onset Alzhiemer

before age of 65 and above age of 50

Diagnostic Test: levels of Neurofilaments (NfL) in serum

Late onset Alzhiemer

Above the age of 65

Diagnostic Test: levels of Neurofilaments (NfL) in serum

Vascular dementia

Any patient diagnosed with vascular dementia

Diagnostic Test: levels of Neurofilaments (NfL) in serum

control group

persons who has no dementia

Diagnostic Test: levels of Neurofilaments (NfL) in serum

Interventions

the levels Neurofilaments (NfL) (Abcam, USA), C-X-C motif chemokine 13 (CXCL13) and Chitinase 3-like Protein 1 (Sigma-aldrich, Germany) will be determined in the serum and CSF (if available) in the different participant groups.

Early onset AlzhiemerLate onset AlzhiemerVascular dementiacontrol group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

case control study, it will include 4 groups of dementia patients in early and late onset, and control healthy group matching with age, sex and educational state. The study will include 19 patient of each dementia type and 19 controls, each dementia patients were diagnosed according to the international classification of disease 10th revision ICD 10. Total score of Mini-mental state examination is \<24 or 22 in Mini-mental state examination will be used as a screening test for detection of cases.

You may qualify if:

  • Men or women of at least 50-80 years of age.
  • Are reliable in individual data and willing to make themselves available for the duration of the study
  • Clear written informed consent obtained from 1st degree of relative from each patient participant and control himself in the trial.

You may not qualify if:

  • age below 50 years and above 80 years.
  • other neurological disorders or psychiatric disorders; previous history of stroke; metabolic disturbance; other major medical illnesses; epilepsy; inflammatory, autoimmune, or infectious disease; metallic objects in the body; craniotomy in the past.
  • Presence of clinically significant medical or psychiatric condition that may increase the risk associated with the study
  • Participation in any other type of medical research that may interfere with the interpretation of the study.
  • Patients with severe motor disability (bed-ridden) that may interfere with the study procedure.
  • Patients with history of seizures or epilepsy including history in a first degree relative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicine

Asyut, Egypt

RECRUITING

Related Publications (3)

  • Antczak J, Rusin G, Slowik A. Transcranial Magnetic Stimulation as a Diagnostic and Therapeutic Tool in Various Types of Dementia. J Clin Med. 2021 Jun 28;10(13):2875. doi: 10.3390/jcm10132875.

    PMID: 34203558BACKGROUND
  • Elshahidi MH, Elhadidi MA, Sharaqi AA, Mostafa A, Elzhery MA. Prevalence of dementia in Egypt: a systematic review. Neuropsychiatr Dis Treat. 2017 Mar 6;13:715-720. doi: 10.2147/NDT.S127605. eCollection 2017.

    PMID: 28293113BACKGROUND
  • Weston PSJ, Poole T, Ryan NS, Nair A, Liang Y, Macpherson K, Druyeh R, Malone IB, Ahsan RL, Pemberton H, Klimova J, Mead S, Blennow K, Rossor MN, Schott JM, Zetterberg H, Fox NC. Serum neurofilament light in familial Alzheimer disease: A marker of early neurodegeneration. Neurology. 2017 Nov 21;89(21):2167-2175. doi: 10.1212/WNL.0000000000004667. Epub 2017 Oct 25.

    PMID: 29070659BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Eman M Khedr, professor

    Assiut University

    STUDY CHAIR

Central Study Contacts

Esraa A Abdelregal, Ass lecturer

CONTACT

Noha M Aboelfetoh, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 23, 2023

Study Start

March 10, 2023

Primary Completion

July 21, 2025

Study Completion

February 21, 2026

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations