Biomarkers of Cognitive Impairment in Blood Cells

Mild Cognitive Impairment Due to Alzheimer's Disease Clinical Trial

— COGNIMARK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05582941
• Other study ID #: IB 3799/18 PI
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: January 26, 2024

Study information

• Verified date: October 2022
• Source: University of the Balearic Islands
• Contact: Paula Oliver, Professor
• Phone: +34-971172548
• Email: paula.oliver[@]uib.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 26, 2024
• Est. primary completion date: January 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Disease
• Mild Cognitive Impairment Due to Alzheimer's Disease

Intervention

Other:
• No intervention will be performed.
No intervention will be performed.

Locations

Country	Name	City	State
Spain	University of the Balearic Islands	Palma, Mallorca	Balearic Islands

Sponsors (3)

Lead Sponsor	Collaborator
University of the Balearic Islands	Consorcio Centro de Investigación Biomédica en Red, M.P., Fundació d'investigació Sanitària de les Illes Balears

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Mini-Mental State Examination (MMSE), questionnaire (numerical scale)	Cognitive test	Baseline point (all groups)
Primary	Montreal Cognitive Assessment (MoCA), questionnaire (numerical scale)	Cognitive test	Baseline point (all groups)
Primary	Cognitive Reserve Questionnaire (CRIq), questionnaire (numerical scale)	Cognitive test	Baseline point (all groups)
Primary	Body composition (fat mass)	Percentage of fat mass measured using a dual energy x-ray absorptiometry (DXA) scanner	Baseline point (all groups)
Secondary	Height (cm)	Basic anthropometric parameter, measured in centimeters with a tape-measure	Baseline point (all groups)
Secondary	Weight (kg)	Basic anthropometric parameter, measured using a scale	Baseline point (all groups)
Secondary	Waist-hip ratio (numerical ratio)	Basic anthropometric parameter. Waist circumference (cm) and hip circumference (cm) will be combined to report waist-hip ratio (waist(cm)/hip(cm))	Baseline point (all groups)
Secondary	Blood pressure (mm Hg)	Basic anthropometric parameter, measured in millimeters of mercury with a blood pressure monitor	Baseline point (all groups)
Secondary	Body Mass Index (BMI) (kg/m2)	Basic anthropometric parameter. Weight and height will be combined to report BMI in kg/m^2	Baseline point (all groups)
Secondary	Complete blood count test (numbers of cells/mcL)	Circulating parameter (from blood sample). It will be measured: red blood cells, white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils) and platelets. All of them measured in numbers of cells/mcL by a complete blood count test.	Baseline point (all groups)
Secondary	Plasma glucose (mg/dL)	Circulating parameter (from blood sample)	Baseline point (all groups)
Secondary	Triglycerides (TG, mg/dL)	Circulating parameter (from blood sample)	Baseline point (all groups)
Secondary	Total cholesterol (mg/dL)	Circulating parameter (from blood sample)	Baseline point (all groups)
Secondary	High-density lipoprotein cholesterol (HDL-C,mg/dL)	Circulating parameter (from blood sample)	Baseline point (all groups)
Secondary	Low-density lipoprotein cholesterol (LDL-C, mg/dL)	Circulating parameter (from blood sample)	Baseline point (all groups)
Secondary	Aspartate aminotransferase (AST, U/L)	Circulating parameter (from blood sample)	Baseline point (all groups)
Secondary	Alanine aminotransferase (ALT, U/L)	Circulating parameter (from blood sample)	Baseline point (all groups)
Secondary	Gamma-glutamyl transpeptidase (GGT, U/L)	Circulating parameter (from blood sample)	Baseline point (all groups)
Secondary	Transpeptidase (GGT, U/L)	Circulating parameter (from blood sample)	Baseline point (all groups)
Secondary	C-reactive protein (CRP, mg/dL)	Circulating parameter (from blood sample)	Baseline point (all groups)
Secondary	Apolipoprotein E (APOE, mg/dL)	Circulating parameter (from blood sample)	Baseline point (all groups)
Secondary	Glycated hemoglobin (HbA1c, %)	Circulating parameter (from blood sample)	Baseline point (all groups)
Secondary	Test on nutritional habits, questionnaire (numerical scale)	Lifestyle test. Test on nutritional habits based on a 14-item Mediterranean diet questionnaire	Baseline point (all groups)
Secondary	International Physical Activity Questionnaire, IPAQ (numerical scale)	Lifestyle test, specifically a physical activity test	Baseline point (all groups)
Secondary	STOP-BANG Sleep Apnea Questionnaire (numerical scale)	Lifestyle test, specifically a screening for obstructive sleep apnea in adults	Baseline point (all groups)
Secondary	Gait Speed Test (m/s)	Gait speed is recorded on a 4 meter walkway with 2 meter non-instrumented walkway segments at each end to allow for acceleration and deceleration. Gait speed recorded is the average of the speed for the two trials	Baseline point (all groups)

External Links

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