A Double-blind, Placebo-controlled, Randomized INTerventional Clinical Trial (SARA-INT)
United States, Belgium233 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 range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline to 6 Months in Gait Speed for 400 Meter Walking (MW) Test
. 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
. 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.