DementiaNCT05781139
Comparative Study Between Alzheimer's and Multi-infarct Dementia
An observational study of Dementia, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Dementia
- What is being tested?
- levels of Neurofilaments (NfL) in serum
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2023to 21 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Medicine
Asyut
Esraa A Abdelregal, ass lecturer, 00201033400846, esraa161292@gmail.com
Noha M Aboelfotoh, Professor, 00201006800910, nohaaboelfetoh@aun.edu.eg
About this study
Official title: Comparative Study Between Alzheimer's and Multi-infarct Dementia Regarding to Clinical Aspect, Biomarker, and Cortical Excitability
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.
Read the 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
- Being tested
- levels of Neurofilaments (NfL) in serum
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levels of Neurofilaments (NfL) in serumDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Early onset Alzhiemer | before age of 65 and above age of 50 Receives: Diagnostic Test: levels of Neurofilaments (NfL) in serum | |
| Late onset Alzhiemer | Above the age of 65 Receives: Diagnostic Test: levels of Neurofilaments (NfL) in serum | |
| Vascular dementia | Any patient diagnosed with vascular dementia Receives: Diagnostic Test: levels of Neurofilaments (NfL) in serum | |
| control group | persons who has no dementia Receives: Diagnostic Test: levels of Neurofilaments (NfL) in serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start10 Mar 2023
- Primary completion21 Jul 2025 (estimated)
- Study completion21 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AAEsraa, Assiut University
- Investigators
- Eman M Khedr, professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781139
- Sponsor's protocol ID
- Dementia
- Status last verified
- Mar 2023
- First submitted
- 20 Feb 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- Individual data sharing
- No
Publications
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.
PubMed 34203558Elshahidi 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.
PubMed 28293113Weston 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.
PubMed 29070659
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Alzheimer's and Multi-infarct Dementia Regarding to Clinical Aspect, Biomarker, and Cortical Excitability
- ClinicalTrials.gov ID
- NCT05781139
- Acronym / sponsor ID
- Dementia
- Conditions
- Dementia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 21 Jul 2025 (estimated)
- Study completion
- 21 Feb 2026 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early onset Alzhiemer | – | Diagnostic Test: levels of Neurofilaments (NfL) in serumbefore age of 65 and above age of 50 |
| Late onset Alzhiemer | – | Diagnostic Test: levels of Neurofilaments (NfL) in serumAbove the age of 65 |
| Vascular dementia | – | Diagnostic Test: levels of Neurofilaments (NfL) in serumAny patient diagnosed with vascular dementia |
| control group | – | Diagnostic Test: levels of Neurofilaments (NfL) in serumpersons who has no dementia |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levels of Neurofilaments (NfL) in serumthe 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. | Diagnostic test | Early onset Alzhiemer, Late onset Alzhiemer, Vascular dementia, control group |
Primary outcome
detect difference between multiple types of dementia (Alzheimer's disease with early onset, and late-onset as well as multi-infarct dementia )
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Background: PubMed 34203558Antczak 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.
- Background: PubMed 28293113Elshahidi 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.
- Background: PubMed 29070659Weston 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman M Khedr, professor study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa A Abdelregal, Ass lecturer (00201033400846, esraa161292@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detect difference between multiple types of dementia (Alzheimer's disease with early onset, and late-onset as well as multi-infarct dementia ) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05781139, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.