Multimodal Biomarkers in Individual With Cognitive Impairment and Dementia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial 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)
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
75 Participants
are grouped into 3 trial groupsGroup A: Dementia
Group B: Mild Cognitive impairment
Group C: control
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline (single time point)2
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)
Time frame
Baseline (single time point)3
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
Time frame
Baseline (single time point)Secondary outcomes
1
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
Time frame
Baseline (single time point)2
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
Time frame
Baseline (single time point)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: