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Completed

NCT Number: NCT05582941

Biomarkers of Cognitive Impairment in Blood Cells

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.

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Key information

Conditions

Mild Cognitive Impairment Due to Alzheimer's Disease Alzheimer Disease Body Weight Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Dementia Due to Alzheimer's Disease (Disorder) Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Tauopathies

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of the Balearic Islands

Palma, Mallorca, Balearic Islands, 07122, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Control group

Inclusion criteria

  • Age between 55-80 years
  • Absence of cognitive symptoms
  • Normal neuropsychological examination, (Clinical Dementia Rating, CDR = 0)

Exclusion criteria

  • Any disease that could influence their cognitive performance or blood cell parameters.
  • Group with Mild Cognitive Impairment Due to Alzheimer's Disease (MCI group)

Inclusion criteria

  • Age between 55-80 years
  • Established diagnosis of MCI
  • Cognitive deficit of 1.5 standard deviation in at least one of the neuropsychological tests performed, with no relevant functional repercussion (Functional Activities Questionnaire, FAQ<7 and CDR≤0.5)
  • Group with Dementia Due to Alzheimer Disease (AD)

Inclusion criteria

  • Age between 55-80 years
  • Established diagnosis of Alzheimer's disease
  • CDR ≥ 0.5 and positive AD markers in cerebrospinal fluid

Treatment and study plan

No intervention will be performed.

Other

No intervention will be performed.

Primary outcomes

  1. Percentage of semiquantitative gene expression of blood cells between the three groups

    Time frame: 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

  2. Mini-Mental State Examination (MMSE), questionnaire (numerical scale)

    Time frame: Baseline point (all groups)

    Cognitive test

  3. Montreal Cognitive Assessment (MoCA), questionnaire (numerical scale)

    Time frame: Baseline point (all groups)

    Cognitive test

  4. Cognitive Reserve Questionnaire (CRIq), questionnaire (numerical scale)

    Time frame: Baseline point (all groups)

    Cognitive test

  5. Body composition (fat mass)

    Time frame: Baseline point (all groups)

    Percentage of fat mass measured using a dual energy x-ray absorptiometry (DXA) scanner

Secondary outcomes

  1. Height (cm)

    Time frame: Baseline point (all groups)

    Basic anthropometric parameter, measured in centimeters with a tape-measure

  2. Weight (kg)

    Time frame: Baseline point (all groups)

    Basic anthropometric parameter, measured using a scale

  3. Waist-hip ratio (numerical ratio)

    Time frame: 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))

  4. Blood pressure (mm Hg)

    Time frame: Baseline point (all groups)

    Basic anthropometric parameter, measured in millimeters of mercury with a blood pressure monitor

  5. Body Mass Index (BMI) (kg/m2)

    Time frame: Baseline point (all groups)

    Basic anthropometric parameter. Weight and height will be combined to report BMI in kg/m^2

  6. Complete blood count test (numbers of cells/mcL)

    Time frame: 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.

  7. Plasma glucose (mg/dL)

    Time frame: Baseline point (all groups)

    Circulating parameter (from blood sample)

  8. Triglycerides (TG, mg/dL)

    Time frame: Baseline point (all groups)

    Circulating parameter (from blood sample)

  9. Total cholesterol (mg/dL)

    Time frame: Baseline point (all groups)

    Circulating parameter (from blood sample)

  10. High-density lipoprotein cholesterol (HDL-C,mg/dL)

    Time frame: Baseline point (all groups)

    Circulating parameter (from blood sample)

  11. Low-density lipoprotein cholesterol (LDL-C, mg/dL)

    Time frame: Baseline point (all groups)

    Circulating parameter (from blood sample)

  12. Aspartate aminotransferase (AST, U/L)

    Time frame: Baseline point (all groups)

    Circulating parameter (from blood sample)

  13. Alanine aminotransferase (ALT, U/L)

    Time frame: Baseline point (all groups)

    Circulating parameter (from blood sample)

  14. Gamma-glutamyl transpeptidase (GGT, U/L)

    Time frame: Baseline point (all groups)

    Circulating parameter (from blood sample)

  15. Transpeptidase (GGT, U/L)

    Time frame: Baseline point (all groups)

    Circulating parameter (from blood sample)

  16. C-reactive protein (CRP, mg/dL)

    Time frame: Baseline point (all groups)

    Circulating parameter (from blood sample)

  17. Apolipoprotein E (APOE, mg/dL)

    Time frame: Baseline point (all groups)

    Circulating parameter (from blood sample)

  18. Glycated hemoglobin (HbA1c, %)

    Time frame: Baseline point (all groups)

    Circulating parameter (from blood sample)

  19. Test on nutritional habits, questionnaire (numerical scale)

    Time frame: Baseline point (all groups)

    Lifestyle test. Test on nutritional habits based on a 14-item Mediterranean diet questionnaire

  20. International Physical Activity Questionnaire, IPAQ (numerical scale)

    Time frame: Baseline point (all groups)

    Lifestyle test, specifically a physical activity test

  21. STOP-BANG Sleep Apnea Questionnaire (numerical scale)

    Time frame: Baseline point (all groups)

    Lifestyle test, specifically a screening for obstructive sleep apnea in adults

  22. Gait Speed Test (m/s)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of the Balearic Islands

Other

Collaborators

  • Consorcio Centro de Investigación Biomédica en Red (CIBER)
  • Fundació d'investigació Sanitària de les Illes Balears

Registry information

Official study title

Use of Human Blood Cells for the Identification of Early Biomarkers of Cognitive Damage

Acronym: COGNIMARK

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 17, 2022
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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