Biomarkers of Cognitive Impairment in Blood Cells (COGNIMARK)

July 1, 2025 updated by: University of the Balearic Islands

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline point (all groups)
Mini-Mental State Examination (MMSE), questionnaire (numerical scale)
Time Frame: Baseline point (all groups)
Cognitive test
Baseline point (all groups)
Montreal Cognitive Assessment (MoCA), questionnaire (numerical scale)
Time Frame: Baseline point (all groups)
Cognitive test
Baseline point (all groups)
Cognitive Reserve Questionnaire (CRIq), questionnaire (numerical scale)
Time Frame: Baseline point (all groups)
Cognitive test
Baseline point (all groups)
Body composition (fat mass)
Time Frame: Baseline point (all groups)
Percentage of fat mass measured using a dual energy x-ray absorptiometry (DXA) scanner
Baseline point (all groups)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Height (cm)
Time Frame: Baseline point (all groups)
Basic anthropometric parameter, measured in centimeters with a tape-measure
Baseline point (all groups)
Weight (kg)
Time Frame: Baseline point (all groups)
Basic anthropometric parameter, measured using a scale
Baseline point (all groups)
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))
Baseline point (all groups)
Blood pressure (mm Hg)
Time Frame: Baseline point (all groups)
Basic anthropometric parameter, measured in millimeters of mercury with a blood pressure monitor
Baseline point (all groups)
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
Baseline point (all groups)
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.
Baseline point (all groups)
Plasma glucose (mg/dL)
Time Frame: Baseline point (all groups)
Circulating parameter (from blood sample)
Baseline point (all groups)
Triglycerides (TG, mg/dL)
Time Frame: Baseline point (all groups)
Circulating parameter (from blood sample)
Baseline point (all groups)
Total cholesterol (mg/dL)
Time Frame: Baseline point (all groups)
Circulating parameter (from blood sample)
Baseline point (all groups)
High-density lipoprotein cholesterol (HDL-C,mg/dL)
Time Frame: Baseline point (all groups)
Circulating parameter (from blood sample)
Baseline point (all groups)
Low-density lipoprotein cholesterol (LDL-C, mg/dL)
Time Frame: Baseline point (all groups)
Circulating parameter (from blood sample)
Baseline point (all groups)
Aspartate aminotransferase (AST, U/L)
Time Frame: Baseline point (all groups)
Circulating parameter (from blood sample)
Baseline point (all groups)
Alanine aminotransferase (ALT, U/L)
Time Frame: Baseline point (all groups)
Circulating parameter (from blood sample)
Baseline point (all groups)
Gamma-glutamyl transpeptidase (GGT, U/L)
Time Frame: Baseline point (all groups)
Circulating parameter (from blood sample)
Baseline point (all groups)
Transpeptidase (GGT, U/L)
Time Frame: Baseline point (all groups)
Circulating parameter (from blood sample)
Baseline point (all groups)
C-reactive protein (CRP, mg/dL)
Time Frame: Baseline point (all groups)
Circulating parameter (from blood sample)
Baseline point (all groups)
Apolipoprotein E (APOE, mg/dL)
Time Frame: Baseline point (all groups)
Circulating parameter (from blood sample)
Baseline point (all groups)
Glycated hemoglobin (HbA1c, %)
Time Frame: Baseline point (all groups)
Circulating parameter (from blood sample)
Baseline point (all groups)
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
Baseline point (all groups)
International Physical Activity Questionnaire, IPAQ (numerical scale)
Time Frame: Baseline point (all groups)
Lifestyle test, specifically a physical activity test
Baseline point (all groups)
STOP-BANG Sleep Apnea Questionnaire (numerical scale)
Time Frame: Baseline point (all groups)
Lifestyle test, specifically a screening for obstructive sleep apnea in adults
Baseline point (all groups)
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
Baseline point (all groups)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of the Balearic Islands

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundació d'investigació Sanitària de les Illes Balears
Consorcio Centro de Investigación Biomédica en Red (CIBER)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paula Oliver, Professor, University of the Balearic Islands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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