Global iLCT program for Parkinson’s expanding efforts for treatments
Research program aiming for multiarm, multistage clinical trial platforms
A dozen years after its first meeting, the International Linked Clinical Trials (iLCT) program is continuing to expand upon its ongoing efforts to ultimately heighten the number of treatment options in Parkinson’s disease and improve patients’ quality of life.
The patient-centered global program, a collaboration of the U.K.’s Cure Parkinson’s and the U.S.-based Van Andel Institute, seeks to identify therapies that potentially could slow, halt, or even reverse the progressive neurodegenerative disorder. It focuses primarily on treatments already approved for other conditions.
To date, the program’s committee — a group of Parkinson’s disease experts — has reviewed 171 drugs, according to Cure Parkinson’s, which states in an update on its website that this work “has translated into 21 completed and 20 ongoing clinical trials of iLCT-evaluated drugs, taking place around the world.”
In the last 12 years, more than 4,700 Parkinson’s patients globally have participated in iLCT-related trials, according to a paper titled “Twelve Years of Drug Prioritization to Help Accelerate Disease Modification Trials in Parkinson’s Disease: The International Linked Clinical Trials Initiative,” published in the Journal of Parkinson’s Disease.
In that review, the researchers “discuss a few of the lessons that have been learnt, and we conclude with a perspective on what the next decade may bring, including the introduction of multi-arm, multi-stage clinical trial platforms and the possibility of combination therapies for [Parkinson’s disease].”
On its website update, Cure Parkinson’s states: “We hope these efforts will help to accelerate not only the regulatory process, but also the time it takes to get these therapies to people with Parkinson’s.”
Program launched in 2012 to help advance Parkinson’s treatments
The iLCT, begun in 2012, hosts an annual meeting to assess and prioritize prospective Parkinson’s therapies with the hope that by choosing compounds or treatment candidates with the greatest potential for success, more prospectively disease-modifying therapies will move into clinical studies.
Its committee is comprised of more than 20 leading Parkinson’s experts from across the globe who conduct evaluations based on information from laboratory studies, observations from large data sets, and where applicable, patient experiences.
While some experimental Parkinson’s treatments the committee reviews show strong promise, they lack key evidence that would justify their advancement to clinical study, the charity organization noted. To help with that, Cure Parkinson’s created its grant-funded iLCT Pipeline Research Acceleration Program, which aims to erode such barriers by commissioning the preclinical lab-based studies required to gain the necessary documentation.
In 2023, Cure Parkinson’s and Van Andel renewed their financial support of the iLCT, pledging an additional $4.5 million to fund Parkinson’s research.
It’s through these continued efforts that it is hoped that the impact of the iLCT program will extend beyond increasing the number of clinical trials to seeing new and varied treatment options being made available in the clinic and, eventually, seeing improvements in quality of life for people with Parkinson’s.
The organization also is working to ensure that any therapy candidate found effective in clinical studies will be ready for regulatory approval. To that end, it is collaborating with regulators early in such approval processes, to can help fortify the case for ultimately making the treatment available.
“It’s through these continued efforts that it is hoped that the impact of the iLCT program will extend beyond increasing the number of clinical trials to seeing new and varied treatment options being made available in the clinic and, eventually, seeing improvements in quality of life for people with Parkinson’s,” the website update notes.
iLCT has reviewed almost one-third of disease-modifying therapies in trials
Cure Parkinson’s stresses that patients are at the core of the iLCT program, from participating in committee meetings and conversations about the viability of the potential treatment under discussion, to their involvement in the planning of clinical studies, and taking part in research.
Through last January, the committee had evaluated nearly 30% of potentially disease-modifying Parkinson’s treatments in clinical trials, according to Cure Parkinson’s.
Key ongoing clinical studies involving iLCT-prioritized drugs include a Phase 3 trial (NCT04232969) led by University College London (UCL) that involves the approved diabetes treatment exenatide. Another UCL Phase 3 study (NCT05778617) aims to test the ability of the respiratory treatment ambroxol to slow Parkinson’s progression.
Additionally, a Cure Parkinson’s-supported Phase 2 study (NCT03840005) of the bile-duct treatment ursodeoxycholic acid provided evidence to encourage further clinical assessments in Parkinson’s patients. Most recently, a Phase 2 study (NCT03439943) of lixisenatide, another approved diabetes treatment, showed a significant slowing of Parkinson’s motor symptom progression. That study was supported by Cure Parkinson’s, Van AI, and the French Ministry of Health.
“It has been my privilege to be involved with the iLCT [program], which has been transformational for Parkinson’s research,” said Camille Carroll, PhD, a professor of clinical neuroscience at the University of Plymouth, in England, and the iLCT co-chair.
“The iLCT programme has at its core, principles that underpin its success — patient-centredness, collaboration and transparency. The initiative continues to evolve to meet the needs of the changing international landscape of disease modification trials in Parkinson’s, ensuring its outputs are as relevant and impactful today as they were at its inception,” Carroll stated.
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