Comparative Study Between Alzheimer's and Multi-infarct Dementia

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05781139
Collaborator
(none)
76
1
35.4
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: levels of Neurofilaments (NfL) in serum

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
76 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Comparative Study Between Alzheimer's and Multi-infarct Dementia Regarding to Clinical Aspect, Biomarker, and Cortical Excitability
Actual Study Start Date :
Mar 10, 2023
Anticipated Primary Completion Date :
Jul 21, 2025
Anticipated Study Completion Date :
Feb 21, 2026

Arms and Interventions

Arm Intervention/Treatment
Early onset Alzhiemer

before age of 65 and above age of 50

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.

Late onset Alzhiemer

Above the age of 65

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.

Vascular dementia

Any patient diagnosed with vascular dementia

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.

control group

persons who has no dementia

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.

Outcome Measures

Primary Outcome Measures

  1. detect difference between multiple types of dementia (Alzheimer's disease with early onset, and late-onset as well as multi-infarct dementia ) [2 years]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medicine Assiut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Chair: Eman M Khedr, professor, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
AAEsraa, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier:
NCT05781139
Other Study ID Numbers:
  • Dementia
First Posted:
Mar 23, 2023
Last Update Posted:
Mar 23, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 23, 2023