FrailtyAGE-IT-FRAILTYNCT06324149
Age-related Conditions in the Context of Multimorbidity and Frailty: Relative Weight of Frailty in Determining the Course and Outcomes of Different Chronic Diseases and Viceversa
An observational study of Frailty and Sarcopenia, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Observational study. Participants of the FRASNET study (9th March 2017, Protocol No. 24/INT/2017) who were evaluated in 2016 and 2017 will be contacted to be re-evaluated with multidimensional visits as part of the present study in order to assess trajectories and biomarkers of frailty and sarcopenia. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Frailty, Sarcopenia
- What is being tested?
- completion of scales and questionnaires; venous blood sampling; muscle ultrasound; cardiac ultrasound; electrocardiogram; bioelectrical impedance analysis
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 7 Mar 2024to 30 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- Adult, Older adult
Study population: * 1250 individuals of the FRASNET study (original promoter of the study Ospedale San Raffaele, Principal Investigator Professor Paolo Manunta): older volunteers who were either robust or frail at the evaluations performed in 2016-2017 ) * 720 patients suffering from cognitive impairment and clinically followed at the Neurology Department of the San Raffaele Hospital (UniSR Prof Agosta)
Who may be able to join
- Having participated in the FRASNET study or being a patient with mild cognitive impairment or dementia followed up at the Neurologic Unit of the San Raffaele Hospital
- Ability to sign written informed consent
- > 18 years old
Who cannot join
- Life expectancy < 6 months
- Unwillingness to participate in the study
- Unstable clinical disease(for ex. serious acute pathologies)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
San Raffaele Hospital
Milan
Patrizia Rovere Querini, PhD,MD, +390226433065, rovere.patrizia@hsr.it
Sarah Damanti, PhD,MD, +390226436095, damanti.sarah@hsr.it
About this study
Observational study. Participants of the FRASNET study (9th March 2017, Protocol No. 24/INT/2017) who were evaluated in 2016 and 2017 will be contacted to be re-evaluated with multidimensional visits as part of the present study in order to assess trajectories and biomarkers of frailty and sarcopenia. Moreover, are going to evaluate with the same multidimensional visits patients with mild cognitive impairment and dementia followed up at the Neurologic Unit of the San Raffaele Hospital.
- Conditions
- Frailty, Sarcopenia
- Being tested
- completion of scales and questionnaires; venous blood sampling; muscle ultrasound; cardiac ultrasound; electrocardiogram; bioelectrical impedance analysis
- Medical subject headings
- Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
completion of scales and questionnaires; venous blood sampling; muscle ultrasound; cardiac ultrasound; electrocardiogram; bioelectrical impedance analysisDiagnostic test
The sub-investigator performs a multidimentional geriatric evaluation
| Study group | Role | What they receive |
|---|---|---|
| older volunteers | 1250 individuals of the FRASNET study (original promoter of the study Ospedale San Raffaele, Principal Investigator Professor Paolo Manunta): older volunteers who were either robust or frail at the evaluations performed in 2016-2017)
* completion of scales and questionnaires
* venous blood sampling
* muscle ultrasound
* cardiac ultrasound
* electrocardiogram
* bioelectrical impedance analysis Receives: Diagnostic Test: completion of scales and questionnaires; venous blood sampling; muscle ultrasound; cardiac ultrasound; electrocardiogram; bioelectrical impedance analysis | |
| neurology patients | 720 patients suffering from cognitive impairment and clinically followed at the Neurology Department of the San Raffaele Hospital (UniSR Prof Agosta)
* completion of scales and questionnaires
* venous blood sampling
* muscle ultrasound
* cardiac ultrasound
* electrocardiogram
* bioelectrical impedance analysis Receives: Diagnostic Test: completion of scales and questionnaires; venous blood sampling; muscle ultrasound; cardiac ultrasound; electrocardiogram; bioelectrical impedance analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
identify new molecular markers of frailty and sarcopenia
To identify new molecular markers of frailty and sarcopenia in elderly volunteers and patients suffering from mild cognitive impairment and dementia assay of biomarkers (HMGB1, sRAGE, FGF21, GFD15 and neurofilaments)
Measured: febbrary 2026
Secondary outcomes (1)
evaluate the ability of new markers for frailty, sarcopenia, cognitive impairment
To evaluate the ability of new markers (identified through the analysis of biobanked blood samples) to predict individual trajectories of frailty, sarcopenia, cognitive impairment and clinical outcomes assay of biomarkers (HMGB1, sRAGE, FGF21, GFD15 and neurofilaments)
Measured: april 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start7 Mar 2024
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rovere Querini Patrizia, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324149
- Sponsor's protocol ID
- AGE-IT-FRAILTY
- Acronym
- AGE-IT-FRAILTY
- Status last verified
- Jun 2025
- First submitted
- 5 Mar 2024
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-related Conditions in the Context of Multimorbidity and Frailty: Relative Weight of Frailty in Determining the Course and Outcomes of Different Chronic Diseases and Viceversa
- ClinicalTrials.gov ID
- NCT06324149
- Acronym / sponsor ID
- AGE-IT-FRAILTY / AGE-IT-FRAILTY
- Conditions
- Frailty, Sarcopenia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 21 Mar 2024 (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.
Observational study. Participants of the FRASNET study (9th March 2017, Protocol No. 24/INT/2017) who were evaluated in 2016 and 2017 will be contacted to be re-evaluated with multidimensional visits as part of the present study in order to assess trajectories and biomarkers of frailty and sarcopenia. Moreover, are going to evaluate with the same multidimensional visits patients with mild cognitive impairment and dementia followed up at the Neurologic Unit of the San Raffaele Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| older volunteers | – | Diagnostic Test: completion of scales and questionnaires; venous blood sampling; muscle ultrasound; cardiac ultrasound; electrocardiogram; bioelectrical impedance analysis1250 individuals of the FRASNET study (original promoter of the study Ospedale San Raffaele, Principal Investigator Professor Paolo Manunta): older volunteers who were either robust or frail at the evaluations performed in 2016-2017) * completion of scales and questionnaires * venous blood sampling * muscle ultrasound * cardiac ultrasound * electrocardiogram * bioelectrical impedance analysis |
| neurology patients | – | Diagnostic Test: completion of scales and questionnaires; venous blood sampling; muscle ultrasound; cardiac ultrasound; electrocardiogram; bioelectrical impedance analysis720 patients suffering from cognitive impairment and clinically followed at the Neurology Department of the San Raffaele Hospital (UniSR Prof Agosta) * completion of scales and questionnaires * venous blood sampling * muscle ultrasound * cardiac ultrasound * electrocardiogram * bioelectrical impedance analysis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * 1250 individuals of the FRASNET study (original promoter of the study Ospedale San Raffaele, Principal Investigator Professor Paolo Manunta): older volunteers who were either robust or frail at the evaluations performed in 2016-2017 ) * 720 patients suffering from cognitive impairment and clinically followed at the Neurology Department of the San Raffaele Hospital (UniSR Prof Agosta)
Key inclusion criteria (3 listed)
- Having participated in the FRASNET study or being a patient with mild cognitive impairment or dementia followed up at the Neurologic Unit of the San Raffaele Hospital
- Ability to sign written informed consent
- > 18 years old
Key exclusion criteria (3 listed)
- Life expectancy < 6 months
- Unwillingness to participate in the study
- Unstable clinical disease(for ex. serious acute pathologies)
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 |
|---|---|---|
| completion of scales and questionnaires; venous blood sampling; muscle ultrasound; cardiac ultrasound; electrocardiogram; bioelectrical impedance analysisThe sub-investigator performs a multidimentional geriatric evaluation | Diagnostic test | neurology patients, older volunteers |
Primary outcome
identify new molecular markers of frailty and sarcopenia
Time frame: febbrary 2026
To identify new molecular markers of frailty and sarcopenia in elderly volunteers and patients suffering from mild cognitive impairment and dementia assay of biomarkers (HMGB1, sRAGE, FGF21, GFD15 and neurofilaments)
1 secondary outcome
evaluate the ability of new markers for frailty, sarcopenia, cognitive impairment
Time frame: april 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Frailty and Sarcopenia, run by IRCCS San Raffaele at 1 site in Italy.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 Jun 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrizia Rovere Querini, PhD, MD (+390226433065, rovere.patrizia@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identify new molecular markers of frailty and sarcopenia (time frame: febbrary 2026). 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 22 Jun 2025.