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

Not yet recruiting

• Conditions: Frailty; Sarcopenia
• Interventions: Diagnostic Test: completion of scales and questionnaires; venous blood sampling; muscle ultrasound; cardiac ultrasound; electrocardiogram; bioelectrical impedance analysis

• Registration Number: NCT06324149
• Lead Sponsor: IRCCS San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21
• Study Start: 2024-04-01
• Primary Completion: 2026-02-28
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
neurology patients	completion of scales and questionnaires; venous blood sampling; muscle ultrasound; cardiac ultrasound; electrocardiogram; bioelectrical impedance analysis	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
older volunteers	completion of scales and questionnaires; venous blood sampling; muscle ultrasound; cardiac ultrasound; electrocardiogram; bioelectrical impedance analysis	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

Primary Outcome Measures

Name	Time	Method
identify new molecular markers of frailty and sarcopenia	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)

Secondary Outcome Measures

Name	Time	Method
evaluate the ability of new markers for frailty, sarcopenia, cognitive impairment	april 2026	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)

Trial Locations

Locations (1)

San Raffaele Hospital; 🇮🇹 Milan, Italy