Biomarkers of Cognitive Impairment in Blood Cells

NCT05582941 | Completed

• 1 other identifier: IB 3799/18 PI
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• 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)

Secondary Outcomes (22)

• Height (cm)

  Baseline point (all groups)

• Weight (kg)

  Baseline point (all groups)

• Waist-hip ratio (numerical ratio)

  Baseline point (all groups)

• Blood pressure (mm Hg)

  Baseline point (all groups)

• Body Mass Index (BMI) (kg/m2)

  Baseline point (all groups)

Study Arms (3)

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.

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.

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.

Interventions

No intervention will be performed. OTHER

No intervention will be performed.

Control; Dementia due to Alzheimer Disease: AD group; Mild Cognitive Impairment Due to Alzheimer's Disease: MCI group

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age between 55-80 years
• Absence of cognitive symptoms
• Normal neuropsychological examination, (Clinical Dementia Rating, CDR = 0)

You may not qualify if:

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

Sponsors & Collaborators

• University of the Balearic Islands: lead
• Fundació d'investigació Sanitària de les Illes Balears: collaborator
• Consorcio Centro de Investigación Biomédica en Red (CIBER): collaborator

Study Sites (1)

University of the Balearic Islands

Palma, Mallorca, Balearic Islands, 07122, Spain

Location

Related Links

• Article from the research group that supports the relation between normal-weight obesity in rodents and cognitive impairment in rats.

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for analysis of gene expression and general clinical parameters

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Obesity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paula Oliver, Professor

  University of the Balearic Islands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: October 17, 2022
• Study Start: April 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: July 4, 2025

Record last verified: 2023-06

Locations

ES (1)