Roatan

Researchers are investigating the safety and effects of a gene therapy that delivers the Klotho gene using a nonviral plasmid in healthy adults aged 23 to 90 years. This early phase study aims to better understand how this gene therapy may impact cognitive abilities and overall health, including kidney function and lifespan. The study is sponsored by Minicircle and includes detailed monitoring of biological and cognitive changes over time. Participants will receive the Klotho gene therapy through a subcutaneous injection into abdominal fat. The study does not involve a placebo group and is conducted partly outside the U.S. for the treatment administration, while pre- and post-treatment assessments occur at a U.S. site. Throughout the study, participants will undergo multiple blood draws, cognitive tests, brain function measurements, and health screenings at scheduled intervals before and after receiving the gene therapy. During the trial, participants will be evaluated with various blood tests to measure serum markers and hormones related to kidney and metabolic function. Cognitive tests and brain imaging assessments will also be conducted repeatedly to assess changes in cognitive performance and brain age. Safety is closely monitored by tracking adverse events reported by participants. The study includes visits extending up to six months after treatment, with detailed follow-up to understand the therapys impact on quality of life and health markers.

This research aims to investigate the safety and effects of a combination gene therapy using klotho and follistatin in healthy adults aged 50 to 80 years. The study evaluates how this nonviral plasmid gene therapy may impact cognitive and physical health, including potential improvements in physical function, kidney function, body composition, and subjective well-being. It is an early-phase interventional trial conducted by the sponsor Minicircle. Participants will receive the gene therapy through a subcutaneous injection into abdominal fat. The treatment is administered at a site outside the U.S., while pre- and post-treatment assessments, including cognitive and health testing, occur within the U.S. The study involves monitoring changes in various biological markers and health measures over several months following treatment. During the study, participants will undergo evaluations such as blood tests, cognitive assessments, and physical performance tests before treatment and at multiple follow-up visits up to three months after therapy. Researchers will measure serum levels of klotho and follistatin, track any treatment-related adverse events, and assess changes in quality of life, cognitive test scores, biological age markers, physical function, and various laboratory parameters. This comprehensive monitoring aims to gather detailed information about the therapys safety and potential health benefits.