What the trial was testing
The KARMET enrolled 151 patients with parkinson's disease. The study was sponsored by Enterin Inc. and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
People on ENT-01 went from less than 1 bowel movement per week to more than 3 per week.
Annals of internal medicine · 2022 · NCT03781791
These findings — that up from less than 1 per week before treatment — were published in the Annals of internal medicine and represent the headline result of the study.
Researchers tracked outcomes across 151 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with parkinson's disease, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This was an early-stage study and ENT-01 is not yet FDA-approved. The treatment was well-tolerated with mainly nausea and diarrhea as side effects. If you have Parkinson's and struggle with constipation, ask your doctor about open trials testing ENT-01 or other options to manage this symptom.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open parkinson's disease trials
tDCS on Parkinson's Disease Cognition
Parkinson's disease (PD) has been classically regarded as a "movement disorder", so earlier work has focused on treating motor symptoms only. As PD patients now have longer life expectancy, the relatively slowly progressing cognitive deficits (compared to their motor deficits) have become one of the major challenges. Approximately 80% of PD patients eventually become demented. Therefore cognitive dysfunction is one of the most significant factors affecting the quality of life of patients with PD. While dementia in Parkinson's disease is routinely treated by cholinesterase inhibitors (e.g., donepezil and rivastigmine), their efficacy on mild cognitive impairment found in non-demented PD is questionable. Alternative approaches have been proposed including transcranial direct current stimulation (tDCS) but no consensus has been reached. This can be attributed mainly to: (1) imprecise knowledge of the underlying functional circuitry mediating this disease manifestation and (2) inter-individual variability. Here, the investigators will utilize a novel personalized network analysis approach to elucidate on the underlying mechanisms of the effect of tDCS on cognitive dysfunction in non-demented PD patients. It has been well documented that the caudate nucleus plays an important role in cognitive dysfunction found in PD. In the investigators' preliminary resting-state functional magnetic resonance imaging (fMRI) study, they have shown that the connectivity of the right caudate nucleus is correlated to cognitive status of PD patients measured by the Montreal Cognitive Assessment (MoCA). The investigators hypothesize that tDCS on the left and/or right dorsolateral prefrontal cortex may restore the functional connectivity of the right caudate nucleus which may in turn improve patients' cognitive performance.
Effects of Amazonian Dance on Motor and Non-motor Symptoms of People With Parkinson's: Study Protocol
This randomized controlled trial aims to evaluate the effects of a 12-week Amazonian dance program on cognitive and motor symptoms in people with Parkinson's disease (PD), comparing outcomes between participants in the intervention and those in an alternative control intervention.