Comparative Study Between Alzheimer's and Multi-infarct Dementia

Dementia Clinical Trial

Official title:

Comparative Study Between Alzheimer's and Multi-infarct Dementia Regarding to Clinical Aspect, Biomarker, and Cortical Excitability

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05781139
• Other study ID #: Dementia
• Status: Recruiting
• Start date: March 10, 2023
• Est. completion date: February 21, 2026

Study information

• Verified date: March 2023
• Source: Assiut University
• Contact: Esraa A Abdelregal, Ass lecturer
• Phone: 00201033400846
• Email: esraa161292[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: February 21, 2026
• Est. primary completion date: July 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• CADASIL
• Dementia
• Dementia, Multi-Infarct

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Egypt	Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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