Biomarkers of Cognitive Impairment in Blood Cells (COGNIMARK)

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

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment Due to Alzheimer's Disease; Dementia Due to Alzheimer's Disease (Disorder)
• Intervention / Treatment: Other: No intervention will be performed.

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 Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Spain
  • Balearic Islands
    • Palma, Mallorca, Balearic Islands, Spain, 07122
      • University of the Balearic Islands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All of the participants are from Spain.

• Control group: the majority are recruited from an Adult University (UOM, Universitat Oberta per Majors, University of the Balearic Island).
• Mild Cognitive Impairment and Alzheimer Disease groups: are recruited from the University Hospital, Son Espases, Mallorca, Spain.

Description

1. 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.

2. 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)
3. 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; 20 individuals with no cognitive alterations or any other pathology which could alter cognitive performance or blood cells	Other: No intervention will be performed.; No intervention will be performed.
Mild Cognitive Impairment Due to Alzheimer's Disease: MCI group; 20 individuals diagnosed with Mild Cognitive Impairment Due to Alzheimer's Disease with positive AD markers in cerebrospinal fluid	Other: No intervention will be performed.; No intervention will be performed.
Dementia due to Alzheimer Disease: AD group; 20 individuals diagnosed with Dementia Due to Alzheimer Disease with positive AD markers in cerebrospinal fluid	Other: No intervention will be performed.; No intervention will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of semiquantitative gene expression of blood cells between the three 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	Baseline point (all groups)
Mini-Mental State Examination (MMSE), questionnaire (numerical scale)	Cognitive test	Baseline point (all groups)
Montreal Cognitive Assessment (MoCA), questionnaire (numerical scale)	Cognitive test	Baseline point (all groups)
Cognitive Reserve Questionnaire (CRIq), questionnaire (numerical scale)	Cognitive test	Baseline point (all groups)
Body composition (fat mass)	Percentage of fat mass measured using a dual energy x-ray absorptiometry (DXA) scanner	Baseline point (all groups)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height (cm)	Basic anthropometric parameter, measured in centimeters with a tape-measure	Baseline point (all groups)
Weight (kg)	Basic anthropometric parameter, measured using a scale	Baseline point (all groups)
Waist-hip ratio (numerical ratio)	Basic anthropometric parameter. Waist circumference (cm) and hip circumference (cm) will be combined to report waist-hip ratio (waist(cm)/hip(cm))	Baseline point (all groups)
Blood pressure (mm Hg)	Basic anthropometric parameter, measured in millimeters of mercury with a blood pressure monitor	Baseline point (all groups)
Body Mass Index (BMI) (kg/m2)	Basic anthropometric parameter. Weight and height will be combined to report BMI in kg/m^2	Baseline point (all groups)
Complete blood count test (numbers of cells/mcL)	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.	Baseline point (all groups)
Plasma glucose (mg/dL)	Circulating parameter (from blood sample)	Baseline point (all groups)
Triglycerides (TG, mg/dL)	Circulating parameter (from blood sample)	Baseline point (all groups)
Total cholesterol (mg/dL)	Circulating parameter (from blood sample)	Baseline point (all groups)
High-density lipoprotein cholesterol (HDL-C,mg/dL)	Circulating parameter (from blood sample)	Baseline point (all groups)
Low-density lipoprotein cholesterol (LDL-C, mg/dL)	Circulating parameter (from blood sample)	Baseline point (all groups)
Aspartate aminotransferase (AST, U/L)	Circulating parameter (from blood sample)	Baseline point (all groups)
Alanine aminotransferase (ALT, U/L)	Circulating parameter (from blood sample)	Baseline point (all groups)
Gamma-glutamyl transpeptidase (GGT, U/L)	Circulating parameter (from blood sample)	Baseline point (all groups)
Transpeptidase (GGT, U/L)	Circulating parameter (from blood sample)	Baseline point (all groups)
C-reactive protein (CRP, mg/dL)	Circulating parameter (from blood sample)	Baseline point (all groups)
Apolipoprotein E (APOE, mg/dL)	Circulating parameter (from blood sample)	Baseline point (all groups)
Glycated hemoglobin (HbA1c, %)	Circulating parameter (from blood sample)	Baseline point (all groups)
Test on nutritional habits, questionnaire (numerical scale)	Lifestyle test. Test on nutritional habits based on a 14-item Mediterranean diet questionnaire	Baseline point (all groups)
International Physical Activity Questionnaire, IPAQ (numerical scale)	Lifestyle test, specifically a physical activity test	Baseline point (all groups)
STOP-BANG Sleep Apnea Questionnaire (numerical scale)	Lifestyle test, specifically a screening for obstructive sleep apnea in adults	Baseline point (all groups)
Gait Speed Test (m/s)	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	Baseline point (all groups)

Collaborators and Investigators

• Sponsor: University of the Balearic Islands
• Collaborators: Fundació d'investigació Sanitària de les Illes Balears; Consorcio Centro de Investigación Biomédica en Red (CIBER)
• Investigators: Principal Investigator: Paula Oliver, Professor, University of the Balearic Islands

Publications and helpful links

Helpful Links

• Article from the research group that supports the relation between normal-weight obesity in rodents and cognitive impairment in rats.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment; Nutrition; Alzheimer Disease; Adiposity; Blood cells
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Pathologic Processes; Neurocognitive Disorders; Cognition Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Cognitive Dysfunction; Alzheimer Disease; Disease
• Other Study ID Numbers: IB 3799/18 PI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual Participant Data (IPD) will be shared in due time if considered relevant for other research. With our current objectives, it is not considered necessary.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No