Clinical trial NCT05582941: Biomarkers of Cognitive Impairment in Blood Cells
Official title: Use of Human Blood Cells for the Identification of Early Biomarkers of Cognitive Damage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Cognitive Impairment Due to Alzheimer's Disease
Dementia Due to Alzheimer's Disease (Disorder)
Keywords: Mild Cognitive Impairment
Alzheimer Disease
Blood cells
Adiposity
Nutrition
Lead sponsor: University of the Balearic Islands
Sponsor class: OTHER
Collaborators: name: Fundació d'investigació Sanitària de les Illes Balears
name: Consorcio Centro de Investigación Biomédica en Red (CIBER)
First posted: 2022-10-17
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

Brief 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. In addition, this project will analyse the influence of adiposity, obesity, nutritional habits and physical activity on cognition.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of semiquantitative gene expression of blood cells between the three groups
timeFrame: Baseline point (all groups)
measure: Mini-Mental State Examination (MMSE), questionnaire (numerical scale)
timeFrame: Baseline point (all groups)
measure: Montreal Cognitive Assessment (MoCA), questionnaire (numerical scale)
timeFrame: Baseline point (all groups)
measure: Cognitive Reserve Questionnaire (CRIq), questionnaire (numerical scale)
timeFrame: Baseline point (all groups)
measure: Body composition (fat mass)
timeFrame: Baseline point (all groups)
Secondary outcomes:
measure: Height (cm)
timeFrame: Baseline point (all groups)
measure: Weight (kg)
timeFrame: Baseline point (all groups)
measure: Waist-hip ratio (numerical ratio)
timeFrame: Baseline point (all groups)
measure: Blood pressure (mm Hg)
timeFrame: Baseline point (all groups)
measure: Body Mass Index (BMI) (kg/m2)
timeFrame: Baseline point (all groups)
measure: Complete blood count test (numbers of cells/mcL)
timeFrame: Baseline point (all groups)
measure: Plasma glucose (mg/dL)
timeFrame: Baseline point (all groups)
measure: Triglycerides (TG, mg/dL)
timeFrame: Baseline point (all groups)
measure: Total cholesterol (mg/dL)
timeFrame: Baseline point (all groups)
measure: High-density lipoprotein cholesterol (HDL-C,mg/dL)
timeFrame: Baseline point (all groups)
measure: Low-density lipoprotein cholesterol (LDL-C, mg/dL)
timeFrame: Baseline point (all groups)
measure: Aspartate aminotransferase (AST, U/L)
timeFrame: Baseline point (all groups)
measure: Alanine aminotransferase (ALT, U/L)
timeFrame: Baseline point (all groups)
measure: Gamma-glutamyl transpeptidase (GGT, U/L)
timeFrame: Baseline point (all groups)
measure: Transpeptidase (GGT, U/L)
timeFrame: Baseline point (all groups)
measure: C-reactive protein (CRP, mg/dL)
timeFrame: Baseline point (all groups)
measure: Apolipoprotein E (APOE, mg/dL)
timeFrame: Baseline point (all groups)
measure: Glycated hemoglobin (HbA1c, %)
timeFrame: Baseline point (all groups)
measure: Test on nutritional habits, questionnaire (numerical scale)
timeFrame: Baseline point (all groups)
measure: International Physical Activity Questionnaire, IPAQ (numerical scale)
timeFrame: Baseline point (all groups)
measure: STOP-BANG Sleep Apnea Questionnaire (numerical scale)
timeFrame: Baseline point (all groups)
measure: Gait Speed Test (m/s)
timeFrame: Baseline point (all groups)
Other outcomes:
Locations:
city: Palma, Mallorca
country: Spain
facility: University of the Balearic Islands
state: Balearic Islands
Study officials:
affiliation: University of the Balearic Islands
name: Paula Oliver, Professor
role: PRINCIPAL_INVESTIGATOR
References: