Adaptive Research Inc., in collaboration with PhotoPharmics Inc., has initiated a decentralized clinical trial to evaluate a novel phototherapy for Parkinson's disease. The LIGHT-PD trial will investigate the efficacy of PhotoPharmics' Celeste® Specialized Phototherapy in improving both motor and non-motor symptoms associated with Parkinson's.
The LIGHT-PD trial is a double-blind, randomized, placebo-controlled study designed to assess the safety and efficacy of Celeste® phototherapy as an adjunct treatment to standard medical care for Parkinson's disease. Parkinson's disease, a progressive neurodegenerative disorder, affects millions worldwide, leading to significant motor and non-motor impairments. Current treatments offer symptomatic relief but do not halt disease progression, creating a substantial unmet medical need.
The decentralized design of the LIGHT-PD trial aims to enhance accessibility and convenience for participants. "The decentralized approach of the LIGHT-PD trial is revolutionizing Parkinson's research," said study investigator Kristin Andruska, MD, PhD. "Using remote, home-based assessments, Adaptive Research can now include participants from a wide geography. This not only provides a more diverse patient population but also makes the trial accessible to those who might otherwise be unable to participate. It's an exciting step towards more inclusive clinical research."
Trial Design and Objectives
The LIGHT-PD trial will enroll patients across multiple sites, including the California Movement Disorders Center, part of Adaptive Research’s network. Participants will undergo remote monitoring through telehealth visits, reducing the burden of frequent in-person clinic visits. The primary endpoint of the trial is to demonstrate a statistically significant improvement in motor and non-motor symptoms compared to placebo. Secondary endpoints include assessments of quality of life, sleep, and cognitive function.
Celeste® phototherapy delivers specific wavelengths of light intended to restore retinal signaling, which may improve function and quality of life for those living with Parkinson’s Disease. Recent scientific discoveries suggest that the eyes play a crucial role in the signaling process related to Parkinson's Disease.
Implications for Parkinson's Treatment
The LIGHT-PD trial has received FDA Breakthrough Designation, underscoring the potential of Celeste® phototherapy to address a significant unmet need in Parkinson's disease management. If successful, this decentralized trial model could pave the way for more inclusive and accessible clinical research, particularly for neurodegenerative disorders. "The at-home, telemedicine-based design of this trial aligns perfectly with Adaptive Research's vision for the future of clinical studies," said Deepak Behera, MD, CEO of Adaptive Research. "It exemplifies our commitment to enhancing accessibility and convenience, enabling broader participation across diverse populations and geographies."
