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RecruitingNCT06324149AGE-IT-FRAILTYUpdated Jun 22, 2025

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 in Frailty and Sarcopenia, sponsored by IRCCS San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-06-22.

Sponsored by IRCCS San Raffaele · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 100 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Frailty
  • Sarcopenia
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In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's planned enrollment of 500 is above the median of 120 across 419 observational studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Sampling method
Non-probability sample

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)

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Life expectancy \< 6 months
  • Unwillingness to participate in the study
  • Unstable clinical disease(for ex. serious acute pathologies)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

    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

    Diagnostic Test: completion of scales and questionnaires; venous blood sampling; muscle ultrasound; cardiac ultrasound; electrocardiogram; bioelectrical impedance analysis

Interventions

  • Diagnostic testcompletion of scales and questionnaires; venous blood sampling; muscle ultrasound; cardiac ultrasound; electrocardiogram; bioelectrical impedance analysis

    The sub-investigator performs a multidimentional geriatric evaluation

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What researchers measure

Primary outcomes

  1. 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)

    Time frame: 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)

    Time frame: april 2026

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06324149
Lead sponsor
IRCCS San Raffaele
Responsible party
Rovere Querini Patrizia (Professor, IRCCS San Raffaele) — Principal investigator
First posted
Mar 21, 2024
Start date
Mar 7, 2024
Primary completion
Feb 28, 2026 (estimated)
Completion
Apr 30, 2026 (estimated)
Last update
Jun 22, 2025

Study contacts

Patrizia Rovere Querini, PhD, MD
Contact
rovere.patrizia@hsr.it
+390226433065
Sarah Damanti, PhD, MD
Contact
damanti.sarah@hsr.it
+390226433065

Oversight

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

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