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Mild Cognitive Impairment Due to Alzheimer's DiseaseCOGNIMARKNCT05582941

Biomarkers of Cognitive Impairment in Blood Cells

An observational study of Mild Cognitive Impairment Due to Alzheimer's Disease and Dementia Due to Alzheimer's Disease (Disorder), run by University of the Balearic Islands at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 80 yearsHealthy volunteers can take part
How many people
48 participants
Where
1 siteSpain
Study dates
1 Apr 2022to 31 May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • Age between 55-80 years
  • Absence of cognitive symptoms
  • Normal neuropsychological examination, (Clinical Dementia Rating, CDR = 0)
  • 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)
Show all 10Show fewer
  • Group with Dementia Due to Alzheimer Disease (AD)
  • Age between 55-80 years
  • Established diagnosis of Alzheimer's disease
  • CDR ≥ 0.5 and positive AD markers in cerebrospinal fluid

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University of the Balearic Islands

    Palma, Mallorca, Balearic Islands, 07122

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
No intervention will be performed.
Keywords
Mild Cognitive Impairment, Alzheimer Disease, Blood cells, Adiposity, Nutrition
Medical subject headings
Cognitive Dysfunction, Alzheimer Disease, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No intervention will be performed.Other

    No intervention will be performed.

Study groups in NCT05582941
Study groupRoleWhat they receive
Control20 individuals with no cognitive alterations or any other pathology which could alter cognitive performance or blood cells
Receives: Other: No intervention will be performed.
Mild Cognitive Impairment Due to Alzheimer's Disease: MCI group20 individuals diagnosed with Mild Cognitive Impairment Due to Alzheimer's Disease with positive AD markers in cerebrospinal fluid
Receives: Other: No intervention will be performed.
Dementia due to Alzheimer Disease: AD group20 individuals diagnosed with Dementia Due to Alzheimer Disease with positive AD markers in cerebrospinal fluid
Receives: Other: No intervention will be performed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline point (all groups)

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

    Cognitive test

    Measured: Baseline point (all groups)

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

    Cognitive test

    Measured: Baseline point (all groups)

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

    Cognitive test

    Measured: Baseline point (all groups)

  5. Body composition (fat mass)

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

    Measured: Baseline point (all groups)

Secondary outcomes (22)

  1. Height (cm)

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

    Measured: Baseline point (all groups)

  2. Weight (kg)

    Basic anthropometric parameter, measured using a scale

    Measured: Baseline point (all groups)

  3. 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))

    Measured: Baseline point (all groups)

  4. Blood pressure (mm Hg)

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

    Measured: Baseline point (all groups)

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

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

    Measured: Baseline point (all groups)

  6. 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.

    Measured: Baseline point (all groups)

  7. Plasma glucose (mg/dL)

    Circulating parameter (from blood sample)

    Measured: Baseline point (all groups)

  8. Triglycerides (TG, mg/dL)

    Circulating parameter (from blood sample)

    Measured: Baseline point (all groups)

  9. Total cholesterol (mg/dL)

    Circulating parameter (from blood sample)

    Measured: Baseline point (all groups)

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

    Circulating parameter (from blood sample)

    Measured: Baseline point (all groups)

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

    Circulating parameter (from blood sample)

    Measured: Baseline point (all groups)

  12. Aspartate aminotransferase (AST, U/L)

    Circulating parameter (from blood sample)

    Measured: Baseline point (all groups)

  13. Alanine aminotransferase (ALT, U/L)

    Circulating parameter (from blood sample)

    Measured: Baseline point (all groups)

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

    Circulating parameter (from blood sample)

    Measured: Baseline point (all groups)

  15. Transpeptidase (GGT, U/L)

    Circulating parameter (from blood sample)

    Measured: Baseline point (all groups)

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

    Circulating parameter (from blood sample)

    Measured: Baseline point (all groups)

  17. Apolipoprotein E (APOE, mg/dL)

    Circulating parameter (from blood sample)

    Measured: Baseline point (all groups)

  18. Glycated hemoglobin (HbA1c, %)

    Circulating parameter (from blood sample)

    Measured: Baseline point (all groups)

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

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

    Measured: Baseline point (all groups)

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

    Lifestyle test, specifically a physical activity test

    Measured: Baseline point (all groups)

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

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

    Measured: Baseline point (all groups)

  22. 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

    Measured: Baseline point (all groups)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2022
  2. Study start1 Apr 2022
  3. Primary completion31 May 2023
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05582941
Sponsor's protocol ID
IB 3799/18 PI
Acronym
COGNIMARK
Status last verified
Jun 2023
First submitted
28 Jul 2022
Last updated
4 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Mild Cognitive Impairment Due to Alzheimer's Disease and Dementia Due to Alzheimer's Disease (Disorder), run by University of the Balearic Islands at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of semiquantitative gene expression of blood cells between the three groups (time frame: Baseline point (all groups)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05582941.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.

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