Multimodal Biomarkers in Individual With Cognitive Impairment and Dementia

NCT07812480 | Not Yet Recruiting DMC

• 1 other identifier: Biomarkers of cognition
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Dementia Disorders; Mild Cognitive Impairment (MCI)

Keywords

dementia; cognition; mild cognitive impairment; GFAP

Outcome Measures

Primary Outcomes (3)

• 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

  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)

  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

  Baseline (single time point)

Secondary Outcomes (2)

• Correlation Between Plasma GFAP and MRI Volumetric Measures Across Dementia Etiological Subtypes

  Baseline (single time point)

• Correlation Between Plasma GFAP and EEG Spectral Power Measures Across Dementia Etiological Subtypes

  Baseline (single time point)

Study Arms (3)

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 10, 2026
• Study Start (Estimated): October 10, 2026
• Primary Completion (Estimated): October 10, 2028
• Study Completion (Estimated): March 10, 2029
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share