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Comparative Study Between Alzheimer's and Multi-infarct Dementia

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05781139
Enrollment
76
Registered
2023-03-23
Start date
2023-03-10
Completion date
2026-02-21
Last updated
2023-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

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.

Interventions

DIAGNOSTIC_TESTlevels 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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
detect difference between multiple types of dementia (Alzheimer's disease with early onset, and late-onset as well as multi-infarct dementia )2 yearsdetect 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

Countries

Egypt

Contacts

Primary ContactEsraa A Abdelregal, Ass lecturer
esraa161292@gmail.com00201033400846
Backup ContactNoha M Aboelfetoh, professor
nohaaboelfetoh@aun.edu.eg01006800910

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026