A Double-blind, Placebo Controlled, Randomized INTerventional Clinical Trial (SARA-INT)

Summary

Participation Requirements

Description

SARA-INT is a three- arm interventional, phase 2, randomized, double blind placebo controlled clinical trial. It will be conducted in the EU (Belgium, France and Italy) and in the US. 334 community dwelling older adults (men or women?65 years) reporting loss of physical function and considered at ri...

SARA-INT is a three- arm interventional, phase 2, randomized, double blind placebo controlled clinical trial. It will be conducted in the EU (Belgium, France and Italy) and in the US. 334 community dwelling older adults (men or women?65 years) reporting loss of physical function and considered at risk of mobility disability, will be selected to perform SPPB (Short Physical Performance Battery)1 tests. Those with SPPB scores ? 8 will be selected to perform body composition analysis with DEXA Scan. (DEXA Scans performed no more than 8 weeks before the date of randomization will be acceptable and in that case should not be repeated up to the end of the study visit). Participants with ALM/BMI < 0.789 in men and < 0.512 in women, or ALM <19.75kg in men and <15.02kg in women corresponding to the operational definition of sarcopenia according to the criteria of FNIH, will be definitively included and randomized if other inclusion/exclusion criteria are also satisfied. The overarching objective of SARA-INT clinical trial is to evaluate the efficacy and safety of BIO101 26-week oral administration on the prevention of mobility disability in at-risk, community dwelling older adults (?65 years) reporting loss of physical function over the previous year, and in particular: To estimate treatment effect improvement on physical function after six-month treatment versus placebo in the target population. To estimate treatment effect on decrease of risk of mobility disability after six-month treatment versus placebo in the target population. The primary objective of SARA-INT is to evaluate the effects of two daily doses of BIO101 versus placebo on mobility function as measured by the gait speed during the 400MW test The first key secondary objective is to evaluate the effect of BIO101 on physical function from the patient's perspective using an adapted patient reported outcome (PRO). The second key objective is to assess on a simplified function test, i.e. raising from a chair, a minimal clinically significant benefit on mobility. SARA-INT other secondary objectives are: To assess changes in body composition and specifically on appendicular lean body mass, which is an expression of sarcopenia; To estimate the change of 400MW test as a dichotomous variable, for possible use in further studies; To estimate the effect on muscular strength; To assess the overall change on SPPB as cumulative expression of a physically frail status; To estimate the effect on a sarcopenia specific PRO, in view of future studies. SARA-INT exploratory objectives are: To compare plasma and/or urinary levels of putative biomarkers of sarcopenia and of drug activity, and calculate their correlation with physical function changes over the study duration. To compare change from baseline of the estimated cumulative daily activity as continuously recorded via a connected wearable actimeter device. A selection of physical activity indexes (by actimetry) will be described and a correlation with primary and key secondary outcome will be tested. The study plan is divided in a) screening and randomization phase; and b) treatment and evaluation phase and c) post-treatment follow-up. The recruitment is estimated to last 24 months. The investigational phase will comprise three main visits, the inclusion visit, the 3-month evaluation and the 6-month final evaluation visit, plus an intermediate visit after 1-month focused on safety assessment. Telephone interviews will be conducted at 5 months and 6 weeks after the end of treatment.

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