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Clinical Trials/NCT05582941
NCT05582941
Completed
Not Applicable

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

University of the Balearic Islands1 site in 1 country48 target enrollmentApril 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Cognitive Impairment Due to Alzheimer's Disease
Sponsor
University of the Balearic Islands
Enrollment
48
Locations
1
Primary Endpoint
Body composition (fat mass)
Status
Completed
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
May 31, 2023
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of the Balearic Islands
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Body composition (fat mass)

Time Frame: Baseline point (all groups)

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

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

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

Time Frame: Baseline point (all groups)

Cognitive test

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

Time Frame: Baseline point (all groups)

Cognitive test

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

Time Frame: Baseline point (all groups)

Cognitive test

Secondary Outcomes

  • Height (cm)(Baseline point (all groups))
  • Waist-hip ratio (numerical ratio)(Baseline point (all groups))
  • Blood pressure (mm Hg)(Baseline point (all groups))
  • Weight (kg)(Baseline point (all groups))
  • Body Mass Index (BMI) (kg/m2)(Baseline point (all groups))
  • Complete blood count test (numbers of cells/mcL)(Baseline point (all groups))
  • Plasma glucose (mg/dL)(Baseline point (all groups))
  • Triglycerides (TG, mg/dL)(Baseline point (all groups))
  • Total cholesterol (mg/dL)(Baseline point (all groups))
  • High-density lipoprotein cholesterol (HDL-C,mg/dL)(Baseline point (all groups))
  • Low-density lipoprotein cholesterol (LDL-C, mg/dL)(Baseline point (all groups))
  • Aspartate aminotransferase (AST, U/L)(Baseline point (all groups))
  • Alanine aminotransferase (ALT, U/L)(Baseline point (all groups))
  • Gamma-glutamyl transpeptidase (GGT, U/L)(Baseline point (all groups))
  • Transpeptidase (GGT, U/L)(Baseline point (all groups))
  • C-reactive protein (CRP, mg/dL)(Baseline point (all groups))
  • Apolipoprotein E (APOE, mg/dL)(Baseline point (all groups))
  • Glycated hemoglobin (HbA1c, %)(Baseline point (all groups))
  • Test on nutritional habits, questionnaire (numerical scale)(Baseline point (all groups))
  • International Physical Activity Questionnaire, IPAQ (numerical scale)(Baseline point (all groups))
  • STOP-BANG Sleep Apnea Questionnaire (numerical scale)(Baseline point (all groups))
  • Gait Speed Test (m/s)(Baseline point (all groups))

Study Sites (1)

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