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CompletedNCT03846245AlfaAgeUpdated Jun 9, 2021

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

An observational study in Aging, sponsored by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-09.

Sponsored by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Aging
03

In context

Lead sponsor

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation is the lead sponsor of 22 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Cognitively unimpaired subjects

Inclusion criteria

  1. 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).
  2. Subjects with no subjective cognitive complaints.
  3. Individuals interested in participating in the study who fully understand all the procedures that will be performed.
  4. Explicit participant agreement to undergo all the study procedures, which encompass:

    1. Collection of basic demographic data.
    2. Collection of a blood sample.
  5. 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

Exclusion Criteria:

  1. No signs of subjective cognitive impairment.
  2. 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).
  3. Any significant major psychiatric illness (following DSM-IV diagnosis manual) o diseases that interfere with cognitive function (including major depression disorder, bipolar disorder, schizophrenia).
  4. 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).
  5. Parkinson's disease, epilepsy under treatment and with frequent seizures (>1 /month) in the last year, multiple sclerosis or any other neurodegenerative disease.
  6. Researcher criteria: individuals that have any condition which, under researcher's view, could lead to difficulty complying with the protocol.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
120 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Young adults group

    Cognitively unimpaired 18-25 years old

    Other: No intervention

  • Old adults group

    Cognitively unimpaired \>= 70 years old

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. Concentration of CCL2

    Differences in the concentration of CCL2 between age groups

    Time frame: at inclusion

  2. Concentration of CCL11

    Differences in the concentration of CCL11 between age groups

    Time frame: at inclusion

  3. Concentration of CCL19

    Differences in the concentration of CCL19 between age groups

    Time frame: at inclusion

  4. Concentration of Haptoglobin

    Differences in the concentration of Haptoglobin between age groups

    Time frame: at inclusion

  5. Concentration of B2-microglobulin

    Differences in the concentration of B2-microglobulin between age groups

    Time frame: at inclusion

  6. Concentration of TIMP2

    Differences in the concentration of TIMP2 between age groups

    Time frame: at inclusion

  7. Concentration of CSF2

    Differences in the concentration of CSF22 between age groups

    Time frame: at inclusion

  8. Concentration of GDF11

    Differences in the concentration of GDF11 between age groups

    Time frame: at inclusion

  9. Concentration of oxytoxin

    Differences in the concentration of oxytoxin between age groups

    Time frame: at inclusion

07

Study locations

1 site
  • Barcelonabeta Brain Research Center
    Barcelona, 08005, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03846245
Lead sponsor
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Collaborators
Göteborg University
Responsible party
Sponsor
First posted
Feb 19, 2019
Start date
Jul 12, 2018
Primary completion
May 3, 2019
Completion
Dec 31, 2020
Last update
Jun 9, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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