Biomarkers of Cognitive Impairment in Blood Cells (COGNIMARK)

University of the Balearic Islands

Status: Enrolling

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

Treatments: Other: No intervention will be performed.

Study type: Observational

Funder types: Other

Identifiers

NCT05582941

IB 3799/18 PI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 55 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

60 participants in 3 patient groups

Control

Description:

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

Treatment:

Other: No intervention will be performed.

Mild Cognitive Impairment Due to Alzheimer's Disease: MCI group

Description:

20 individuals diagnosed with Mild Cognitive Impairment Due to Alzheimer's Disease with positive AD markers in cerebrospinal fluid

Treatment:

Other: No intervention will be performed.

Dementia due to Alzheimer Disease: AD group

Description:

20 individuals diagnosed with Dementia Due to Alzheimer Disease with positive AD markers in cerebrospinal fluid

Treatment:

Other: No intervention will be performed.