Dementia DisordersNCT07812480
Multimodal Biomarkers in Individual With Cognitive Impairment and Dementia
An observational study of Dementia Disorders and Mild Cognitive Impairment (MCI), run by Assiut University.
Trial summary
Memory problems can range from normal aging to mild cognitive impairment (MCI) to dementia. This study looks at three ways of measuring what is happening in the brain at each of these stages: a blood test (GFAP), a brain MRI scan, and a brain wave test (EEG). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia Disorders, Mild Cognitive Impairment (MCI)
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2026to 10 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will include three groups matched for age, sex and educational level: from Outpatient clinic of the Department of Neurology and Psychiatry, Assiut University Hospitals healthy controls, patients with mild cognitive impairment (MCI), and patients with dementia of any etiology (Alzheimer's, vascular, Lewy body, frontotemporal and mixed dementia)
Who may be able to join
- Dementia diagnosed according to DSM -5\ with a total Mini-Mental State Examination score < 24 (or < 22 according to educational state), together with a Modified Mini-Mental State Examination (3MS) score < 79 to confirm cognitive impairment.
- Mild cognitive impairment diagnosed according to established diagnostic criteria according to DSM -5.
- Men or women of at least 50 years of age.
- Reliable in individual data and willing to make themselves available for the duration of the study.
- Clear written informed consent obtained from a first-degree relative for each patient participant, and from the control participant himself/herself.
Who cannot join
- age below 50 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
- MRI contraindication (pacemaker, metallic implants, severe claustrophobia).
About this study
Official title: Multimodal Biomarkers in Individual With Cognitive Impairment and Dementia: A Case Control Study
Memory problems can range from normal aging to mild cognitive impairment (MCI) to dementia. This study looks at three ways of measuring what is happening in the brain at each of these stages: a blood test (GFAP), a brain MRI scan, and a brain wave test (EEG). The goal is to see whether combining these three tests can help doctors tell the difference between normal aging, MCI, and dementia more accurately, and whether this approach works well in an Egyptian population, including all common causes of dementia (not only Alzheimer's disease).
Adults aged 50 to 85 will be placed into one of three groups: those with normal memory, those with mild memory problems (MCI), and those with dementia. Everyone will have a memory and thinking assessment, a blood draw, a brain MRI, and a brain wave (EEG) recording. No new medication or treatment is given as part of this study; it involves only assessment and testing. The information gathered may help doctors diagnose memory problems earlier and more accurately in the future.
Read the detailed description
This is a cross-sectional, observational, case-control study designed to characterize and compare plasma glial fibrillary acidic protein (GFAP), quantitative electroencephalography (EEG), and MRI-based brain volumetry across three groups: healthy controls, participants with mild cognitive impairment (MCI), and participants with dementia of any etiology (Alzheimer's, vascular, Lewy body, frontotemporal, or mixed).
Plasma GFAP, an astrocytic activation marker, will be quantified from EDTA-collected blood via automated chemiluminescent immunoassay (Lumipulse or Alinity platform where available) or conventional ELISA. Structural brain volumetry (hippocampal, medial temporal, and whole-brain/ventricular volumes) will be derived from 3-Tesla MRI using a 3D T1-weighted MPRAGE sequence with automated segmentation. Resting-state EEG will be recorded using a 19-channel 10-20 electrode montage for quantitative spectral power analysis across standard frequency bands.
All participants will undergo a standardized clinical and psychometric assessment, including the Montreal Cognitive Assessment (MoCA), Clinical Dementia Rating (CDR), and functional assessment via the Katz Index and Lawton-Brody Instrumental Activities of Daily Living scale, to confirm group classification prior to biomarker collection.
The study addresses a gap in the literature: although plasma GFAP, MRI volumetry, and EEG have each been separately validated as markers of neurodegeneration, few studies have jointly acquired all three modalities within a single cohort spanning the full continuum from normal cognition through dementia, and fewer still have done so in an Egyptian or broader Middle East/North Africa population across all dementia etiologies rather than Alzheimer's disease alone. Findings from this study are intended to inform the development of a combined biomarker panel for earlier and more accurate differentiation between normal cognitive aging, MCI, and dementia.
- Keywords
- dementia, cognition, mild cognitive impairment, GFAP
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dementia | according toDSM -5 , with a total Mini-Mental State Examination score < 24 (or < 22 according to educational state), together with a Modified Mini-Mental State Examination (3MS) score < 79 to confirm cognitive impairment | |
| Mild Cognitive impairment | impairment diagnosed according to established diagnostic criteria | |
| control | healthy group matched age, sex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentration of Glial Fibrillary Acidic Protein (GFAP)main outcome
Measured in picograms per milliliter (pg/mL) via automated chemiluminescent immunoassay (Lumipulse or Alinity platform) or ELISA, from venous blood collected in EDTA tubes
Measured: Baseline (single time point)
Hippocampal Volume on MRI, Whole-Brain Volume on MRI,Ventricular Volume on MRI
Measured in cubic millimeters (mm³), normalized to total intracranial volume, derived from 3-Tesla 3D T1-weighted MPRAGE MRI using automated segmentation software (FreeSurfer)
Measured: Baseline (single time point)
EEG Band Power Alpha , beta , delta , theta
Absolute spectral power (µV²) in the different frequency band , derived from resting-state EEG recorded with a 19-channel 10-20 electrode montage
Measured: Baseline (single time point)
Secondary outcomes (2)
Correlation Between Plasma GFAP and MRI Volumetric Measures Across Dementia Etiological Subtypes
Pearson/Spearman correlation coefficient between plasma GFAP concentration (pg/mL) and MRI-derived regional brain volumes (mm³), calculated separately within Alzheimer's, vascular, Lewy body, frontotemporal, and mixed dementia subgroups
Measured: Baseline (single time point)
Correlation Between Plasma GFAP and EEG Spectral Power Measures Across Dementia Etiological Subtypes
Pearson/Spearman correlation coefficient between plasma GFAP concentration (pg/mL) and EEG band power (µV²), calculated separately within Alzheimer's, vascular, Lewy body, frontotemporal, and mixed dementia subgroups
Measured: Baseline (single time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Oct 2028 (estimated)
- Study completion10 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia DisordersStudies 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
- Retrospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Goda, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812480
- Sponsor's protocol ID
- Biomarkers of cognition
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Biomarkers in Individual With Cognitive Impairment and Dementia: A Case Control Study
- ClinicalTrials.gov ID
- NCT07812480
- Acronym / sponsor ID
- Biomarkers of cognition
- Keywords
- dementia, cognition, mild cognitive impairment, GFAP
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Oct 2028 (estimated)
- Study completion
- 10 Mar 2029 (estimated)
- First posted
- 10 Sep 2026 (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.
Memory problems can range from normal aging to mild cognitive impairment (MCI) to dementia. This study looks at three ways of measuring what is happening in the brain at each of these stages: a blood test (GFAP), a brain MRI scan, and a brain wave test (EEG). The goal is to see whether combining these three tests can help doctors tell the difference between normal aging, MCI, and dementia more accurately, and whether this approach works well in an Egyptian population, including all common causes of dementia (not only Alzheimer's disease).
Adults aged 50 to 85 will be placed into one of three groups: those with normal memory, those with mild memory problems (MCI), and those with dementia. Everyone will have a memory and thinking assessment, a blood draw, a brain MRI, and a brain wave (EEG) recording. No new medication or treatment is given as part of this study; it involves only assessment and testing. The information gathered may help doctors diagnose memory problems earlier and more accurately in the future.
Detailed description
This is a cross-sectional, observational, case-control study designed to characterize and compare plasma glial fibrillary acidic protein (GFAP), quantitative electroencephalography (EEG), and MRI-based brain volumetry across three groups: healthy controls, participants with mild cognitive impairment (MCI), and participants with dementia of any etiology (Alzheimer's, vascular, Lewy body, frontotemporal, or mixed).
Plasma GFAP, an astrocytic activation marker, will be quantified from EDTA-collected blood via automated chemiluminescent immunoassay (Lumipulse or Alinity platform where available) or conventional ELISA. Structural brain volumetry (hippocampal, medial temporal, and whole-brain/ventricular volumes) will be derived from 3-Tesla MRI using a 3D T1-weighted MPRAGE sequence with automated segmentation. Resting-state EEG will be recorded using a 19-channel 10-20 electrode montage for quantitative spectral power analysis across standard frequency bands.
All participants will undergo a standardized clinical and psychometric assessment, including the Montreal Cognitive Assessment (MoCA), Clinical Dementia Rating (CDR), and functional assessment via the Katz Index and Lawton-Brody Instrumental Activities of Daily Living scale, to confirm group classification prior to biomarker collection.
The study addresses a gap in the literature: although plasma GFAP, MRI volumetry, and EEG have each been separately validated as markers of neurodegeneration, few studies have jointly acquired all three modalities within a single cohort spanning the full continuum from normal cognition through dementia, and fewer still have done so in an Egyptian or broader Middle East/North Africa population across all dementia etiologies rather than Alzheimer's disease alone. Findings from this study are intended to inform the development of a combined biomarker panel for earlier and more accurate differentiation between normal cognitive aging, MCI, and dementia.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dementia | – | –according toDSM -5 , with a total Mini-Mental State Examination score < 24 (or < 22 according to educational state), together with a Modified Mini-Mental State Examination (3MS) score < 79 to confirm cognitive impairment |
| Mild Cognitive impairment | – | –impairment diagnosed according to established diagnostic criteria |
| control | – | –healthy group matched age, sex |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include three groups matched for age, sex and educational level: from Outpatient clinic of the Department of Neurology and Psychiatry, Assiut University Hospitals healthy controls, patients with mild cognitive impairment (MCI), and patients with dementia of any etiology (Alzheimer's, vascular, Lewy body, frontotemporal and mixed dementia)
Key inclusion criteria (5 listed)
- Dementia diagnosed according to DSM -5\ with a total Mini-Mental State Examination score < 24 (or < 22 according to educational state), together with a Modified Mini-Mental State Examination (3MS) score < 79 to confirm cognitive impairment.
- Mild cognitive impairment diagnosed according to established diagnostic criteria according to DSM -5.
- Men or women of at least 50 years of age.
- Reliable in individual data and willing to make themselves available for the duration of the study.
- Clear written informed consent obtained from a first-degree relative for each patient participant, and from the control participant himself/herself.
Key exclusion criteria (4 listed)
- age below 50 years .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma Concentration of Glial Fibrillary Acidic Protein (GFAP)main outcome
Time frame: Baseline (single time point)
Measured in picograms per milliliter (pg/mL) via automated chemiluminescent immunoassay (Lumipulse or Alinity platform) or ELISA, from venous blood collected in EDTA tubes
Hippocampal Volume on MRI, Whole-Brain Volume on MRI,Ventricular Volume on MRI
Time frame: Baseline (single time point)
Measured in cubic millimeters (mm³), normalized to total intracranial volume, derived from 3-Tesla 3D T1-weighted MPRAGE MRI using automated segmentation software (FreeSurfer)
EEG Band Power Alpha , beta , delta , theta
Time frame: Baseline (single time point)
Absolute spectral power (µV²) in the different frequency band , derived from resting-state EEG recorded with a 19-channel 10-20 electrode montage
2 secondary outcomes
Correlation Between Plasma GFAP and MRI Volumetric Measures Across Dementia Etiological Subtypes
Time frame: Baseline (single time point)
Correlation Between Plasma GFAP and EEG Spectral Power Measures Across Dementia Etiological Subtypes
Time frame: Baseline (single time point)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia Disorders and Mild Cognitive Impairment (MCI), run by Assiut University.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Concentration of Glial Fibrillary Acidic Protein (GFAP)main outcome (time frame: Baseline (single time point)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.