A Double-blind, Placebo-controlled, Randomized INTerventional Clinical Trial (SARA-INT)
United States233 participantsStarted 2017-02-07
Plain-language summary
The main objective of the study is to evaluate the effect of two daily doses of BIO101 versus placebo on mobility function as measured by gait speed using the 400MW test. The absolute change from baseline in meters/second observed in each treatment group at 6 Month was compared to the placebo group. Due to the Covid pandemic \>50% of data at endpoint was missing, which may have affected the ability of the study to deliver the expected results. Additionally, although the planned duration of treatment was 6 months, it was extended up to 9 months for some participants as a result of the pandemic.
Who can participate
Age range65 Years
SexALL
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Inclusion criteria
✓. Provision of signed and dated informed consent form
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Male or female, aged ≥ 65 years and living in the community, reporting loss of physical function over the last 6-12 months
✓. Short Physical Performance Battery (SPPB) score ≤ 8
✓. ALM/BMI \< 0.789 in men and 0.512 in women, or ALM \< 19.75kg in men and \<15.02kg in women, as measured by DEXA scan
✓. Ability to take oral medication and be willing to adhere to the study intervention regimen.
✓. Agreement to adhere to Lifestyle Considerations throughout study duration
✓. In the US, women and members of minority groups must be included in accordance with the NIH Policy on Inclusion of Women and Minorities as Participants In Research Involving Human participants.
Exclusion criteria
✕
What they're measuring
1
Change From Baseline to 6 Months in Gait Speed for 400 Meter Walking (MW) Test
. Current use of anabolic drugs (e.g. testosterone); current use of Erythropoietin; current use of corticosteroid agents (except local administration route, like eye drops or dermatologic formulations)
✕. Non-menopaused women (however ongoing replacement hormonal treatment is not an exclusion criterion)
✕. Known allergic reactions to components of the investigational drug.
✕. Treatment with another investigational drug or other intervention within three months
✕. Unable to understand and perform the functional tests, as judged by the Investigator
✕. Inability to perform the 400MW test within 15 minutes
✕. Clinical conditions:
✕. Current diagnosis of major psychiatric disorders.