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NCT Number: NCT03846245

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

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.

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Key information

Conditions

Aging

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Barcelonabeta Brain Research Center

Barcelona, 08005, Spain

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women between 18 and 25 years (young adults group) or older than 70 for persons at the time of inclusion (old adults group).
  • 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

Exclusion criteria

  • 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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Concentration of CCL2

    Time frame: at inclusion

    Differences in the concentration of CCL2 between age groups

  2. Concentration of CCL11

    Time frame: at inclusion

    Differences in the concentration of CCL11 between age groups

  3. Concentration of CCL19

    Time frame: at inclusion

    Differences in the concentration of CCL19 between age groups

  4. Concentration of Haptoglobin

    Time frame: at inclusion

    Differences in the concentration of Haptoglobin between age groups

  5. Concentration of B2-microglobulin

    Time frame: at inclusion

    Differences in the concentration of B2-microglobulin between age groups

  6. Concentration of TIMP2

    Time frame: at inclusion

    Differences in the concentration of TIMP2 between age groups

  7. Concentration of CSF2

    Time frame: at inclusion

    Differences in the concentration of CSF22 between age groups

  8. Concentration of GDF11

    Time frame: at inclusion

    Differences in the concentration of GDF11 between age groups

  9. Concentration of oxytoxin

    Time frame: at inclusion

    Differences in the concentration of oxytoxin between age groups

Sponsors and collaborators

Lead sponsor

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Other

Collaborators

  • Göteborg University

Registry information

Official study title

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

Acronym: AlfaAge

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 19, 2019
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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