We invite you for an exclusive conversation with Jonas Bergquist, MD, Ph.D., OMF’s Chief Medical Officer and Director of the Uppsala University Collaboration. Today, Dr. Bergquist sheds light on The Life
Improvement Trial (LIFT), responding to key questions.
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1. We’ve received inquiries about The LIFT trial. Could you provide a brief overview of The LIFT trial?
The LIFT trial is a collaborative effort with David Systrom’s research groups at the Mass General Brigham Hospital of Harvard University. We are now trying to evaluate the combination of treatments with Pyridostigmine (commonly known as Mestinon), together with low-dose naltrexone treatment (LDN) in ME/CFS patients.
We will do it as a four-armed, double-blind, placebo-controlled trial. So, in this case, 40 patients will get a placebo, 40 patients will get a low-dose naltrexone treatment, 40 patients will get Mestinon only, and then 40 patients will get both Mestinon and LDN treatment in combination. We won’t know who gets what; that will be revealed after the study is over. It’s double-blinded to make sure that we don’t get biased by the reports from the patients.
2. What molecular assessments are being done?
We will collect blood samples and urine during, before, and after the treatment and will then monitor molecular features in these biosamples. We do proteomics, which is an in-depth protein analysis, and we will also do metabolomics, which is analyzing small molecules. We will do both targeted and screening methodologies.
In the proteomics, we will do mass spectrometry-driven proteomics with high-resolution mass spectrometry with immunoassay. We will do a targeted analysis of certain cytokines, that is immune cell signaling molecules in the urine and plasma samples. We will also do metabolomics using both mass spectrometry and Nuclear Magnetic Resonance (NMR) analysis. So, we then get a full profile of the metabolomic changes that may occur in the patients during the treatment.
3. How will you measure changes in functional capacity?
It will be measured through Funcap 27, a recently developed survey by Norwegian colleagues led by Christian Sommerfeld and his team. We are very happy to be the first to test this new questionnaire. It’s based on 27 well-tailored questions that the patients will respond to regularly. We will collect responses before the treatment starts, during the treatment with frequent weekly measures, and then after the treatment is over.
We hope that this will respond well to how the patients feel their functionality is changing and also give us an insight into what part of their functions and symptoms are affected by the different treatments. In combination with this questionnaire, we will also ask the patients to carry one of these portable devices, a Garmin device. It will record all the vital parameters, activity, blood measures, and core activities such as stress levels and heart rate variability. This will be a very objective measure for us. We can then correlate that not only to the symptoms responses in the questionnaires but also to general changes in activity when it comes to response to different treatments.
4. How might these two drugs work synergistically together to boost their benefits?
We will also look at the synergistic effect of these two medications, LDN and Mestinon, in combination. We know that they have some different working mechanisms, but we are pretty convinced that in combination they could affect, for instance, brain fog and pain, and hopefully will also help patients with activation. The synergistic effect will be very much of interest for us to see how well that works. The trial will run for three months, and we think that’s very important that we maintain the treatment for such a long time in order to secure the long-term effect of the treatment.
5. What can clinical trials like The LIFT accomplish for people living with ME/CFS and Long COVID?
Well, we think one of the fundamental parts is, of course, how well the treatments work. But in order to make sure that we get objective measures for that, it’s important to do this kind of double-blinded, placebo-controlled study. The combination of the molecular features that we will measure in the blood samples and urine samples collected during the trial will also help us to understand why certain patients respond and why other patients do not. This can help us in the long-term to actually select and subdivide patients for different coming trials.
6. What makes OMF’s approach to research and clinical trials one-of-a-kind?
We are very proud that we are able to launch this first trial, but we are hoping that this will be one out of a long line of trials and tests that will be launched in the coming years. We have been working very closely together with the patients and looked at patient surveys to get an insight into what kind of treatments have been tested and what has had some positive effects on certain subgroups of patients. Based on this, we have made a very great, in-detail selection of potential targets for our trials. We hope this is going to be a positive and fruitful way of reaching fast, progressive clinical research trials. It’s very important for us to make sure that the drugs that we are selecting for our trials are available for large communities. So, we will focus on already approved drugs initially, and make sure that the trials will show efficacy and will be helping a lot of patients on a global perspective.
7. How can the OMF community help accelerate research?
Of course, we are extremely grateful for your support, for your insights, and for your willingness to share your own treatment experiences. That helps us a lot when it comes to selecting good targets for our trials. We also appreciate your support of Open Medicine Foundation, the organization that makes these trials possible. So, that is something we are also very, very grateful for. Thank you very much. I hope I answered some of your questions.
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