Cross-sectional Study for the Identification of Blood Biomarkers in Healthy Young and Old Individuals

NCT03846245 | Completed

• 1 other identifier: AlfaAge/BBRC2018
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Ageing is clearly the most important risk factor for AD and other dementias but, despite the amount of evidence supporting this fact, the exact mechanism that link ageing and AD is still unknown and, up to now, potential therapies for AD by targeting ageing have been poorly explored. This study aims to provide a better understanding of the link between ageing and AD by means of measuring in human blood those factors that have been found to be 'pro-youthful' (GDF-11, CSF2, TIMP-2, oxytocin) or 'pro-aging' (CCL2, CCL11, CCL19, Haptoglobine, B2-microglobuline) in experimental animal models, but have not been comprehensively studied in humans. In this proof-of-concept study these blood factors in extreme groups of age, namely young adults (18-25 yo) and old adults (≥70 yo) will be measured and the hypothesis of whether the 'pro-youthful' and 'pro-ageing' blood factors change throughout age tested. In order to include a wider range of age, human umbilical cord blood and plasma from teenagers (which is already available from a previous study) will also be included. The ultimate goal of this study is to select the more promising blood factors and obtain data on the effect size of the differences that may allow us in the future to design a larger study.

Conditions

Aging

Outcome Measures

Primary Outcomes (9)

• Concentration of CCL2

  Differences in the concentration of CCL2 between age groups

  at inclusion

• Concentration of CCL11

  Differences in the concentration of CCL11 between age groups

  at inclusion

• Concentration of CCL19

  Differences in the concentration of CCL19 between age groups

  at inclusion

• Concentration of Haptoglobin

  Differences in the concentration of Haptoglobin between age groups

  at inclusion

• Concentration of B2-microglobulin

  Differences in the concentration of B2-microglobulin between age groups

  at inclusion

• Concentration of TIMP2

  Differences in the concentration of TIMP2 between age groups

  at inclusion

• Concentration of CSF2

  Differences in the concentration of CSF22 between age groups

  at inclusion

• Concentration of GDF11

  Differences in the concentration of GDF11 between age groups

  at inclusion

• Concentration of oxytoxin

  Differences in the concentration of oxytoxin between age groups

  at inclusion

Study Arms (2)

Young adults group

Cognitively unimpaired 18-25 years old

Other: No intervention

Old adults group

Cognitively unimpaired \>= 70 years old

Other: No intervention

Interventions

No intervention OTHER

No intervention

Old adults group; Young adults group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cognitively unimpaired subjects

You may qualify if:

• Subjects with no subjective cognitive complaints.
• Individuals interested in participating in the study who fully understand all the procedures that will be performed.
• Explicit participant agreement to undergo all the study procedures, which encompass:
• Collection of basic demographic data.
• Collection of a blood sample.
• Give informed consent and agree that no data resulting from the study (which is no clinically relevant) will be given to the participant

You may not qualify if:

• No signs of subjective cognitive impairment.
• Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol. Including: auditive and visual impairment, renal insufficiency under hemodialysis treatment, hepatic cirrhosis, chronic pneumopathy under oxygen therapy, solid organ transplantation, fibromyalgia, active oncologic disease under treatment (excluding localized tumours).
• Any significant major psychiatric illness (following DSM-IV diagnosis manual) o diseases that interfere with cognitive function (including major depression disorder, bipolar disorder, schizophrenia).
• Acquired brain injury: brain traumatic injury with parenchymal or extra-axial macroscopic injury, large vessel ischemic stroke or hemorrhagic stroke, brain tumors or other conditions that may cause acquired brain injury (brain radio- or chemotherapy).
• Parkinson's disease, epilepsy under treatment and with frequent seizures (\>1 /month) in the last year, multiple sclerosis or any other neurodegenerative disease.
• Researcher criteria: individuals that have any condition which, under researcher's view, could lead to difficulty complying with the protocol.

Sponsors & Collaborators

• Barcelonabeta Brain Research Center, Pasqual Maragall Foundation: lead
• Göteborg University: collaborator

Study Sites (1)

Barcelonabeta Brain Research Center

Barcelona, 08005, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum samples

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 19, 2019
• Study Start: July 12, 2018
• Primary Completion: May 3, 2019
• Study Completion: December 31, 2020
• Last Updated: June 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)