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

Sarcopenia Clinical Trial

— AGE-IT-FRAILTY  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06324149
• Other study ID #: AGE-IT-FRAILTY
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: April 30, 2026

Study information

• Verified date: March 2024
• Source: IRCCS San Raffaele
• Contact: Patrizia Rovere Querini, PhD, MD
• Phone: +390226433065
• Email: rovere.patrizia[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: April 30, 2026
• Est. primary completion date: February 28, 2026
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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:

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

Related Conditions & MeSH terms

• Chronic Disease
• Frailty
• Sarcopenia

Intervention

Diagnostic Test:
• completion of scales and questionnaires; venous blood sampling; muscle ultrasound; cardiac ultrasound; electrocardiogram; bioelectrical impedance analysis
The sub-investigator performs a multidimentional geriatric evaluation

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	april 2026