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

NCT06324149 | Recruiting

• 1 other identifier: AGE-IT-FRAILTY
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Frailty; Sarcopenia

Outcome Measures

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)

  febbrary 2026

Secondary Outcomes (1)

• evaluate the ability of new markers for frailty, sarcopenia, cognitive impairment

  april 2026

Study Arms (2)

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

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

The sub-investigator performs a multidimentional geriatric evaluation

neurology patients; older volunteers

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

San Raffaele Hospital

Milan, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

FGF21, GDF15, Nfl, sRAGE, HMGB1

MeSH Terms

Conditions

Frailty; Sarcopenia

Interventions

Blood Specimen Collection; Electrocardiography

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrodiagnosis

Central Study Contacts

Patrizia Rovere Querini, PhD, MD

CONTACT

+390226433065; rovere.patrizia@hsr.it

Sarah Damanti, PhD, MD

CONTACT

+390226433065; damanti.sarah@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 21, 2024
• Study Start: March 7, 2024
• Primary Completion: February 28, 2026
• Study Completion: April 30, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

IT (1)