Biomarkers of Cognitive Impairment in Blood Cells

NCT ID: NCT05582941

Last Updated: 2025-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mild Cognitive Impairment Due to Alzheimer's Disease Dementia Due to Alzheimer's Disease (Disorder)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Control

20 individuals with no cognitive alterations or any other pathology which could alter cognitive performance or blood cells

No intervention will be performed.

Intervention Type 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

No intervention will be performed.

Intervention Type 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

No intervention will be performed.

Intervention Type OTHER

No intervention will be performed.

Interventions

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No intervention will be performed.

No intervention will be performed.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)
3. 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

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)
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundació d'investigació Sanitària de les Illes Balears

OTHER_GOV

Sponsor Role collaborator

Consorcio Centro de Investigación Biomédica en Red (CIBER)

OTHER_GOV

Sponsor Role collaborator

University of the Balearic Islands

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paula Oliver, Professor

Role: PRINCIPAL_INVESTIGATOR

University of the Balearic Islands

Locations

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University of the Balearic Islands

Palma, Mallorca, Balearic Islands, Spain

Site Status

Countries

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Spain

Related Links

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http://pubmed.ncbi.nlm.nih.gov/29566703/

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

Other Identifiers

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IB 3799/18 PI

Identifier Type: -

Identifier Source: org_study_id

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