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The Life Improvement Trial (LIFT)

Study AIM

The Life Improvement Trial (LIFT) aims to investigate two drugs, separately and in combination, Pyridostigmine (commonly known as Mestinon) and Low-Dose Naltrexone (LDN), for efficacy and to research the difference between responders and non-responders.

LEAD INVESTIGATORS
  • David Systrom, MD
  • Jonas Bergquist, MD/PhD
  • Donna Felsenstein, MD
  • Wenzhong Xiao, PhD
Updates and Potential
  • Received IRB approval in July 2024.
  • Patient recruitment and screening began in August 2024, and the first participant was enrolled in September 2024.
  • Additional recruitment methods have been rolled out following the initial enrollment.
  • The team is conducting a retrospective analysis of the two drugs in the LIFT to complement the results of this trial.
    • The sub-maximal CPET database is being updated and patient charts are being mined to gather data for potential dose-related effects for either drug (Mestinon and LDN).
    • The large language model used to analyze electronic health records is being refined.
    • A manuscript is in preparation.
Clinical Trial Description

The lift trial two lead researcher headshots.The LIFT will be conducted at Brigham and Women’s Hospital (BWH) of Harvard Medical School, focusing on the effect of Pyridostigmine (Mestinon) and Low-Dose Naltrexone (LDN) in subjects aged 18-65 meeting the Canadian consensus criteria (CCC) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as well as having specifically Orthostatic Intolerance. Both drugs may be anti-inflammatory, LDN through the blockage of toll-like receptors, and Pyridostigmine through its cholinergic effects.

This double-blind, placebo-controlled study will involve 160 participants randomised into one of four possible arms: Pyridostigmine/LDN (40), Pyridostigmine/Placebo (40), LDN/Placebo (40), Placebo/Placebo (40). The dose of Pyridostigmine will be carefully titrated from 30mg to 60mg three times a day, and the dose of LDN will be titrated from 1.5 mg to 4.5 mg once daily.

The trial includes a scale-back plan, allowing participants to reduce their dosage if they experience intolerance symptoms, with adjustments made during weekly visits. This plan provides a personalised approach to medication tolerance, ensuring participant’s safety and comfort throughout the trial.

The time commitment for the participant is approximately three (3) months, and during this time, there will be three (3) in-person visits to BWH and four (4) virtual visits. Study procedures will include two (2) submaximum cardiopulmonary exercise tests, questionnaires (virtually completed), and blood and urine collection. We will be recruiting from the BWH Dyspnea Clinic as well as the OMF StudyME Registry and anticipate the entire trial will take two (2) years to complete.

OBJECTIVES
  • Gain insights into ME/CFS pathogenesis by evaluating the effects of Pyridostigmine and LDN treatments.
  • Investigate the synergistic effect of the two medications, Pyridostigmine and LDN, when used in combination.
  • Identify which people with ME/CFS are likely to benefit from Pyridostigmine and LDN treatments.
  • Delve into the patient’s physiology with proteomics, metabolomics, and other assessments to find biomarkers that identify responders and enhance the understanding of ME/CFS.
  • Discover a biomarker or biomarker signature that differentiates people with ME/CFS from healthy individuals.
  • Inform the scientific and medical communities about ME/CFS pathogenesis through treatment and testing results.
  • Enable the widespread use of Pyridostigmine and LDN by primary care doctors in the USA, laying the foundation for similar approvals for use by General Practitioners in Australia.
  • Establish the infrastructure necessary for future clinical treatment trials funded by OMF.

Learn more about the LIFT!

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OMF Australia accepts donations of Cryptocurrencies

Make the most of your donation by donating your Bitcoin, Ethereum, and other cryptocurrencies directly to OMF Australia rather than selling and donating the after-tax proceeds.

  • Your tax deduction will be equal to the fair market value of the donated cryptocurrency (as determined by a qualified appraisal).
  • Donors should consult with a tax advisor for properly recording this donation on a personal tax return.


OMF Australia can accept cryptocurrency donations of any amount. 

Donating cryptocurrency is a non-taxable event, meaning you do not owe capital gains tax on the appreciated amount and can deduct it on your taxes. This makes Bitcoin and other cryptocurrency donations one of the most tax-efficient ways to support your favorite cause. If you want to learn more about how donating crypto can lower your taxes, check out thegivingblock.com/faq.

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