SynG: a Music-Based Intervention for Alzheimer's and Mild Cognitive Impairment

/ Abstract In this proposal, Oscilloscape, Inc (dba Oscillo Biosciences) seeks NIH-SBIR funding to develop and test an innovative, wearable digital health device to help aging adults with Alzheimer’s Disease (AD) and Mild Cognitive Impairment (MCI). The device delivers a digital therapy using music and synchronized visual brain stimulation. The wearable device, herein referred to as SynG (“SynchronyGamma”) is based on patented neural network technology that models the dynamics of rhythmic brain activity. SynG aims to stimulate healthy brain rhythms via the process of neural entrainment. In clinical populations who have disruptions in brain rhythms, e.g., patients with AD and MCI, we hypothesize that this technology can effectively restore normal brain activity important for learning, memory, and cognition. Ongoing tests using a prototype tabletop display, 1 hr/day for 8 weeks, are showing that daily use improves memory and cognition relative to controls. Key outcomes of this project are 1) a wearable version of the device with which dosage can be precisely controlled, and 2) an IRB-approved study to assess the level of dosage necessary for a therapeutic neural response. The SynG project has potential to help age-related cognitive impairments by creating a music- based, digital health device that delivers rhythmic brain stimulation via music and synchronized light. Neurodegenerative disorders are a rapidly growing public-health concern, with AD alone projected to affect 13.8 million Americans in 2050. AD patients undergo gradual cognitive decline, with MCI being an early stage of the disorder. During this progression, patients experience multiple pain-points, including memory loss, executive function deficits, and depression. Early intervention in the MCI stage may reduce or even reverse cognitive decline. While pharmacological interventions for AD have primarily targeted biomarkers such as beta-amyloid (Aβ) plaques, these strategies have shown limited success in improving clinical outcomes and they all have potentially serious side-effects. Thus, there is an urgent clinical need to develop novel therapies for AD and MCI. Recent findings that relate neural entrainment to Aβ offer an exciting avenue towards non-invasive sensory interventions. Our goal is to develop a scalable solution that will enhance independence for aging populations with cognitive disorders. The therapy can be delivered in the patient’s own home via a comfortable wearable device and takes 30-60 minutes daily. It is effective, scalable, and non-invasive. It is well-tolerated and does not interact with most traditional pharmaceuticals. The objective of this SBIR project is to create a wearable version of SynG that can be tested for efficacy in a fully powered clinical trial on older adults with mild-to-moderate cognitive impairment. Project Number: 1R43AG092067-01 | Fiscal Year: 2025 | NIH Institute/Center: National Institute on Aging (NIA) | Principal Investigator: Edward Large (+1 co-PI) | Institution: OSCILLOSCAPE, LLC, EAST HARTFORD, CT | Award Amount: $467,538 | Activity Code: R43 | Study Section: Special Emphasis Panel[ZRG1 BP-C (10)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11069277