Comparative Study Between Alzheimer's and Multi-infarct Dementia

NCT ID: NCT05781139

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 76 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-10
• Study Completion Date: 2026-02-21

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.

Detailed Description

Biomarkers are needed to identify at-risk individuals, stage their disease, and track disease progression. Such biomarkers should be noninvasive, inexpensive, and simple to acquire. Neurodegeneration biomarkers in CSF include neurofilament light (NfL), Chitinase 3-like protein 1 (CHI3L1). NfL for example increases in several neurologic conditions, including AD. In addition, NfL can be detected in serum using standard immunoassay formats. Higher CSF levels of CHI3L1 are seen in patients with neurological disorders such as MS patients experiencing relapses of MS. In addition, C-X-C motif chemokine 13 (CXCL13) is a crucial homeostatic chemokine expressed in lymphoid organs, and it is essential for the recruitment and compartmentalization of lymphocytes. In MS, CXCL13 regulates homing of B cells and subsets of T cells to inflammatory foci in CNS by interacting with the CXCR5 receptor. The levels of CXCL13 are elevated in the CSF of patients with MS compared to healthy controls, as well as in other neuroinflammatory diseases. CXCL13 may be considered a CSF biomarker of intrathecal B cell response, as its levels correlate with the count of B cells, the IgG index, and the presence and OCBs in the CSF.

Transcranial magnetic stimulation (TMS) assesses several cortical properties such as excitability, plasticity, and connectivity in humans. TMS has been applied to patients with dementia, enabling the identification of potential markers of the pathophysiology and predictors of cognitive decline; moreover, applied repetitively, TMS holds promise as a potential therapeutic intervention.

Conditions

Dementia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Early onset Alzhiemer

before age of 65 and above age of 50

levels of Neurofilaments (NfL) in serum

Intervention Type: DIAGNOSTIC_TEST

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.

Late onset Alzhiemer

Above the age of 65

levels of Neurofilaments (NfL) in serum

Intervention Type: DIAGNOSTIC_TEST

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.

Vascular dementia

Any patient diagnosed with vascular dementia

levels of Neurofilaments (NfL) in serum

Intervention Type: DIAGNOSTIC_TEST

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.

control group

persons who has no dementia

levels of Neurofilaments (NfL) in serum

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

levels of Neurofilaments (NfL) in serum

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Men or women of at least 50-80 years of age.

2. Are reliable in individual data and willing to make themselves available for the duration of the study

3. Clear written informed consent obtained from 1st degree of relative from each patient participant and control himself in the trial.

Exclusion Criteria

1. age below 50 years and above 80 years.

2. 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.

3. Presence of clinically significant medical or psychiatric condition that may increase the risk associated with the study

4. Participation in any other type of medical research that may interfere with the interpretation of the study.

5. Patients with severe motor disability (bed-ridden) that may interfere with the study procedure.

6. Patients with history of seizures or epilepsy including history in a first degree relative

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

AAEsraa

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman M Khedr, professor

Role: STUDY_CHAIR

Assiut University

Locations

Medicine

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Esraa A Abdelregal, Ass lecturer

Role: CONTACT

esraa161292@gmail.com

00201033400846

Noha M Aboelfetoh, professor

Role: CONTACT

nohaaboelfetoh@aun.edu.eg

01006800910

Facility Contacts

Esraa A Abdelregal, ass lecturer

Role: primary

esraa161292@gmail.com

00201033400846

Noha M Aboelfotoh, Professor

Role: backup

nohaaboelfetoh@aun.edu.eg

00201006800910

References

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.

Reference Type: BACKGROUND

PMID: 34203558 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28293113 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29070659 (View on PubMed)

Other Identifiers

Dementia

Identifier Type: -

Identifier Source: org_study_id