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

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ClinicalTrials.gov Identifier: NCT03846245
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

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.


Condition or disease Intervention/treatment
Aging Other: No intervention

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: AldaAge: Cross-sectional Study for the Identification of Blood Biomarkers in Healthy Young and Old Individuals
Actual Study Start Date : July 12, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : December 31, 2019

Group/Cohort Intervention/treatment
Young adults group
Cognitively unimpaired 18-25 years old
Other: No intervention
No intervention

Old adults group
Cognitively unimpaired >= 70 years old
Other: No intervention
No intervention




Primary Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Plasma and serum samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Cognitively unimpaired subjects
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846245


Contacts
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Contact: Carolina Minguillon, PhD +34933160990 cminguillon@fpmaragall.org

Locations
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Spain
Barcelonabeta Brain Research Center Recruiting
Barcelona, Spain, 08005
Contact: Carolina Minguillon, PhD    933160990    cminguillon@fpmaragall.org   
Sponsors and Collaborators
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Göteborg University

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Responsible Party: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
ClinicalTrials.gov Identifier: NCT03846245     History of Changes
Other Study ID Numbers: AlfaAge/BBRC2018
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No