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| Name | Class |
|---|---|
| Fundació d'investigació Sanità ria de les Illes Balears | OTHER_GOV |
| Consorcio Centro de Investigación Biomédica en Red (CIBER) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | 20 individuals with no cognitive alterations or any other pathology which could alter cognitive performance or blood cells |
| |
| 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 |
| |
| Dementia due to Alzheimer Disease: AD group | 20 individuals diagnosed with Dementia Due to Alzheimer Disease with positive AD markers in cerebrospinal fluid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention will be performed. | Other | No intervention will be performed. |
|
| 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) |
| 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 |
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Control group
Inclusion criteria:
Exclusion criteria:
Group with Mild Cognitive Impairment Due to Alzheimer's Disease (MCI group)
Inclusion criteria:
Group with Dementia Due to Alzheimer Disease (AD)
Inclusion criteria:
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All of the participants are from Spain.
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| Name | Affiliation | Role |
|---|---|---|
| Paula Oliver, Professor | University of the Balearic Islands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of the Balearic Islands | Palma, Mallorca | Balearic Islands | 07122 | Spain |
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| Label | URL |
|---|---|
| Article from the research group that supports the relation between normal-weight obesity in rodents and cognitive impairment in rats. | View source |
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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.
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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Blood samples for analysis of gene expression and general clinical parameters
| 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) |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |