AgingAlfaAgeNCT03846245
Cross-sectional Study for the Identification of Blood Biomarkers in Healthy Young and Old Individuals
An observational study of Aging, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aging
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jul 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Cognitively unimpaired subjects
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AlfaAge: 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.
- Conditions
- Aging
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Young adults group | Cognitively unimpaired 18-25 years old Receives: Other: No intervention | |
| Old adults group | Cognitively unimpaired >= 70 years old Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of CCL2
Differences in the concentration of CCL2 between age groups
Measured: at inclusion
Concentration of CCL11
Differences in the concentration of CCL11 between age groups
Measured: at inclusion
Concentration of CCL19
Differences in the concentration of CCL19 between age groups
Measured: at inclusion
Concentration of Haptoglobin
Differences in the concentration of Haptoglobin between age groups
Measured: at inclusion
Concentration of B2-microglobulin
Differences in the concentration of B2-microglobulin between age groups
Measured: at inclusion
Concentration of TIMP2
Differences in the concentration of TIMP2 between age groups
Measured: at inclusion
Concentration of CSF2
Differences in the concentration of CSF22 between age groups
Measured: at inclusion
Concentration of GDF11
Differences in the concentration of GDF11 between age groups
Measured: at inclusion
Concentration of oxytoxin
Differences in the concentration of oxytoxin between age groups
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start12 Jul 2018
- Primary completion3 May 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846245
- Sponsor's protocol ID
- AlfaAge/BBRC2018
- Acronym
- AlfaAge
- Status last verified
- Jun 2021
- First submitted
- 18 Feb 2019
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AlfaAge: Cross-sectional Study for the Identification of Blood Biomarkers in Healthy Young and Old Individuals
- ClinicalTrials.gov ID
- NCT03846245
- Acronym / sponsor ID
- AlfaAge / AlfaAge/BBRC2018
- Conditions
- Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall FoundationUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 3 May 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young adults group | – | Other: No interventionCognitively unimpaired 18-25 years old |
| Old adults group | – | Other: No interventionCognitively unimpaired >= 70 years old |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cognitively unimpaired subjects
Key inclusion criteria (7 listed)
- 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:
- Give informed consent and agree that no data resulting from the study (which is no clinically relevant) will be given to the participant
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Old adults group, Young adults group |
Primary outcome
Concentration of CCL2
Time frame: at inclusion
Differences in the concentration of CCL2 between age groups
Concentration of CCL11
Time frame: at inclusion
Differences in the concentration of CCL11 between age groups
Concentration of CCL19
Time frame: at inclusion
Differences in the concentration of CCL19 between age groups
Concentration of Haptoglobin
Time frame: at inclusion
Differences in the concentration of Haptoglobin between age groups
Concentration of B2-microglobulin
Time frame: at inclusion
Differences in the concentration of B2-microglobulin between age groups
Concentration of TIMP2
Time frame: at inclusion
Differences in the concentration of TIMP2 between age groups
Concentration of CSF2
Time frame: at inclusion
Differences in the concentration of CSF22 between age groups
Concentration of GDF11
Time frame: at inclusion
Differences in the concentration of GDF11 between age groups
Concentration of oxytoxin
Time frame: at inclusion
Differences in the concentration of oxytoxin between age groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of CCL2 (time frame: at inclusion). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.