Clarity Announces Positive Results from Phase 1 Clinical Study for Novel Alzheimer's Neuromodulation Treatment
Clarity is thrilled to announce positive results from its Phase 1 clinical study for a novel non-invasive neuromodulation treatment. Clarity's groundbreaking approach is the first to deliver 40Hz gamma-frequency light and sound stimulation via virtual reality (VR) technology to address key pathophysiological markers of Alzheimer’s disease (AD), including neuroinflammation and synaptic dysfunction. These results set the stage for a new category of non-invasive, disease-modifying therapies.
The Challenge of Alzheimer’s Disease
Alzheimer’s disease impacts over 55 million people globally and remains one of the most pressing healthcare challenges of our time. Despite recent advancements in anti-amyloid therapies, current treatments often provide limited benefits, come with significant risks, and fail to address the multifaceted nature of the disease. Gamma Sensory Stimulation (GSS) has emerged as a promising neuromodulation technique. By enhancing gamma neural synchrony, GSS offers potential disease-modifying effects, including reducing neuroinflammation, promoting the clearance of amyloid-beta proteins, and improving synaptic plasticity. Clarity’s approach integrates rhythmic 40Hz light and sound stimulation into engaging VR environments, dynamically activating memory-related neural circuits to enhance efficacy while addressing adherence challenges common in static stimulation protocols.
Key Study Findings
The Phase 1 study, conducted with 16 cognitively healthy older adults in California, demonstrated the safety, feasibility, and tolerability of Clarity’s VR-based stimulation treatment. Key findings include:
- Strong Safety and Tolerability Profile: Participants experienced no severe adverse events. Mild, transient side effects, such as brief disorientation or eye strain, were rare and resolved quickly. No participants experienced motion sickness or tinnitus. Most participants rated the experience as enjoyable and the headset as comfortable.
- Significant Gamma Neural Activity Modulation: The VR-based protocol reliably induced gamma oscillatory activity across sensory modalities. Both simple and complex audiovisual stimuli at 40Hz elicited significant increases in gamma power and inter-trial phase coherence (ITPC), critical metrics linked to cognitive processes such as memory and attention.
- Enhanced Engagement and Adherence Potential: Clarity’s approach demonstrated equivalent efficacy in neural modulation using complex multimedia content compared to static stimulation, highlighting the potential to combine therapeutic impact with improved patient engagement, a key factor for long-term adherence.
Click here to read the pre-print: C. Reis, H. Azizollahi, G. Headley, S. Navarro, S. Hanslmayr, A. Clouter, T. Zanto, R. Certain., (2025). VR-based Gamma Sensory Stimulation: A feasibility study (pre-print).
A Step Toward Transformative Care
Clarity’s approach leverages immersive VR technology to create personalized, engaging therapeutic experiences. This study demonstrated the platform’s flexibility in delivering effective stimulation across various sensory modalities and tasks. By embedding stimuli into contextually rich and engaging content, Clarity’s protocol shows promise in targeting specific memory-related brain networks, paving the way for personalized and scalable interventions that can be seamlessly integrated into daily routines, offering hope for millions living with Alzheimer’s and neurodegenerative diseases.
Pioneering the Future of Alzheimer’s Treatment
"This trial represents a breakthrough in demonstrating the synergy between advanced technology and non-pharmacological treatments." said Raphael Certain, Founder & CEO of Clarity. "Our goal is to redefine what’s possible in neurology by delivering therapeutic experiences that are effective, enjoyable, and transformative for patients and families."
Building on these promising results, Clarity is currently conducting a study involving Alzheimer’s patients and preparing for a longitudinal Phase 2 trial. This will further explore the efficacy of Clarity’s protocol in slowing cognitive decline and maintaining functional abilities in those living with AD.
About Clarity
Clarity is a clinical-stage company committed to creating a new standard of care in neurology. By combining cutting-edge neuroscience with advanced engineering, Clarity’s platform delivers scalable, non-invasive therapies designed to address neurodegenerative disease. For more information, visit the Home page