Biomarkers of Cognitive Impairment in Blood Cells

Completed

• Conditions: Dementia Due to Alzheimer's Disease (Disorder); Mild Cognitive Impairment Due to Alzheimer's Disease

• Registration Number: NCT05582941
• Lead Sponsor: University of the Balearic Islands

Brief Summary

The aim of this study is to identify transcriptomic biomarkers in blood cells to diagnose early cognitive impairment. This would allow preventing the development of severe pathologies, such as Alzheimer Disease. In addition, this project will analyse the influence of adiposity, obesity, nutritional habits and physical activity on cognition.

Detailed Description

Blood cells constitute a minimally invasive material, which is presented as potentially suitable for addressing the identification of clinical diagnostic biomarkers. This study will compare gene expression in blood cells of patients with various degrees of cognitive alteration (mild cognitive impairment due to Alzheimer's disease and dementia due to Alzheimer's Disease) compared to control individuals, to identify early biomarkers of impaired cognition. The availability of non-invasive early biomarkers of cognitive dysfunction is highly relevant in the field of public health, from the point of view of being able to prevent or delay the onset and/or progression of dementia and other cognitive disorders. In addition, it is intended to establish the association between the biomarkers identified with nutritional imbalances and increased adiposity/obesity.

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-10-13
• Study First Posted: 2022-10-17
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2023-06
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body composition (fat mass)	Baseline point (all groups)	Percentage of fat mass measured using a dual energy x-ray absorptiometry (DXA) scanner
Percentage of semiquantitative gene expression of blood cells between the three groups	Baseline point (all groups)	Gene expression analysis performed by real-time quantitative polymerase chain reaction (RT-qPCR). Percentage of semiquantitative gene expression between the groups: MCI vs Control, AD vs Control, and MCI vs AD
Mini-Mental State Examination (MMSE), questionnaire (numerical scale)	Baseline point (all groups)	Cognitive test
Montreal Cognitive Assessment (MoCA), questionnaire (numerical scale)	Baseline point (all groups)	Cognitive test
Cognitive Reserve Questionnaire (CRIq), questionnaire (numerical scale)	Baseline point (all groups)	Cognitive test

Secondary Outcome Measures

Name	Time	Method
Height (cm)	Baseline point (all groups)	Basic anthropometric parameter, measured in centimeters with a tape-measure
Weight (kg)	Baseline point (all groups)	Basic anthropometric parameter, measured using a scale
Waist-hip ratio (numerical ratio)	Baseline point (all groups)	Basic anthropometric parameter. Waist circumference (cm) and hip circumference (cm) will be combined to report waist-hip ratio (waist(cm)/hip(cm))
Blood pressure (mm Hg)	Baseline point (all groups)	Basic anthropometric parameter, measured in millimeters of mercury with a blood pressure monitor
Body Mass Index (BMI) (kg/m2)	Baseline point (all groups)	Basic anthropometric parameter. Weight and height will be combined to report BMI in kg/m\^2
Complete blood count test (numbers of cells/mcL)	Baseline point (all groups)	Circulating parameter (from blood sample). It will be measured: red blood cells, white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils) and platelets. All of them measured in numbers of cells/mcL by a complete blood count test.
Plasma glucose (mg/dL)	Baseline point (all groups)	Circulating parameter (from blood sample)
Triglycerides (TG, mg/dL)	Baseline point (all groups)	Circulating parameter (from blood sample)
Total cholesterol (mg/dL)	Baseline point (all groups)	Circulating parameter (from blood sample)
High-density lipoprotein cholesterol (HDL-C,mg/dL)	Baseline point (all groups)	Circulating parameter (from blood sample)
Low-density lipoprotein cholesterol (LDL-C, mg/dL)	Baseline point (all groups)	Circulating parameter (from blood sample)
Aspartate aminotransferase (AST, U/L)	Baseline point (all groups)	Circulating parameter (from blood sample)
Alanine aminotransferase (ALT, U/L)	Baseline point (all groups)	Circulating parameter (from blood sample)
Transpeptidase (GGT, U/L)	Baseline point (all groups)	Circulating parameter (from blood sample)
C-reactive protein (CRP, mg/dL)	Baseline point (all groups)	Circulating parameter (from blood sample)
Glycated hemoglobin (HbA1c, %)	Baseline point (all groups)	Circulating parameter (from blood sample)
Test on nutritional habits, questionnaire (numerical scale)	Baseline point (all groups)	Lifestyle test. Test on nutritional habits based on a 14-item Mediterranean diet questionnaire
International Physical Activity Questionnaire, IPAQ (numerical scale)	Baseline point (all groups)	Lifestyle test, specifically a physical activity test
STOP-BANG Sleep Apnea Questionnaire (numerical scale)	Baseline point (all groups)	Lifestyle test, specifically a screening for obstructive sleep apnea in adults
Gait Speed Test (m/s)	Baseline point (all groups)	Gait speed is recorded on a 4 meter walkway with 2 meter non-instrumented walkway segments at each end to allow for acceleration and deceleration. Gait speed recorded is the average of the speed for the two trials
Gamma-glutamyl transpeptidase (GGT, U/L)	Baseline point (all groups)	Circulating parameter (from blood sample)
Apolipoprotein E (APOE, mg/dL)	Baseline point (all groups)	Circulating parameter (from blood sample)

Trial Locations

Locations (1)

University of the Balearic Islands; 🇪🇸 Palma, Mallorca, Balearic Islands, Spain