Phase 2 human clinical trial in Parkinson’s disease patients

ScandiBio Therapeutics announced Phase 2 clinical trial results from the study “Combined Metabolic Activators Improve Cognitive Functions without Altering Motor Scores in Parkinson’s Disease” on the open-access server medRxiv.org https://www.medrxiv.org/content/10.1101/2021.07.28.21261293v1

ScandiBio Therapeutics designed a randomized, double-blinded, placebo-controlled, phase 2 study in PD patients with CMA administration. The researchers found that cognitive function in PD patients significantly improved by 21% in the CMA group versus an improvement of 11% in the placebo group after 84 days. They also found that administration of CMA did not negatively affect motor function in PD patients.

The findings of the study are consistent with the results of a recently reported AD clinical phase 2 study, where they administered CMA to 60 AD patients using the same protocol https://www.medrxiv.org/content/10.1101/2021.07.14.21260511v2. In the AD study, cognitive function was determined using the AD Assessment Scale-cognitive subscale (ADAS-Cog) score which was improved by 29% in the CMA group vs 14% in the placebo group after 84 days of CMA administration. The approximate 11-14% improvement in the placebo groups in both the PD and AD clinical trials can be explained by the recommendations to incorporate exercise and a Mediterranean diet to all patients. In conclusion, the results show that treating PD and AD patients with CMAs leads to enhanced cognitive function.