- Results from OVERTURE showed Spectris preserved white matter and myelin integrity across multiple brain regions, indicating structural neuroprotection.
- The OVERTURE study demonstrated that Spectris treatment significantly reduced the decline of scale points in ADCS-ADL, MMSE and WBV over 6 months compared to sham treatment.
- Collaboration with Firefly Neuroscience aims to identify EEG biomarkers that correlate with Spectris clinical response.
Cognito Therapeutics, a clinical-stage neurotechnology company pioneering neuromodulation-based treatments for neurodegenerative diseases, announced five new poster presentations at the Alzheimer’s Association International Conference (AAIC) 2025 supporting the clinical efficacy and neuroprotective mechanism of its lead investigational therapy, Spectris™, in patients with Alzheimer’s disease.
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Cognito Spectris investigational device. Image credit: Cognito Therapeutics
Data derived from the OVERTURE feasibility trial and the OVERTURE open label extension study demonstrated that Spectris resulted in significant “time saved” in functional and structural decline over 6 months and significant “time saved” in cognitive, functional and structural decline over 18 months. In the OVERTURE open label extension (OLE), participants treated with Spectris experienced up to 9.9 months of “time saved” across clinical and imaging endpoints. Specifically, Spectris treatment resulted in time savings of 8.66-months in activities of daily living (ADCS-ADL), 9.93-months in cognitive function (MMSE), and 7.48-months in whole brain volume, all with p-values <0.0001.
MRI-based analyses further revealed that Spectris preserved white matter and myelin integrity across multiple brain regions, suggesting a broad structural neuroprotective effect linked to its gamma-frequency (40 Hz) stimulation mechanism. These findings align with AD preclinical models demonstrating brain structure preservation following non-invasive gamma stimulation.
In addition to traditional endpoints, benefits in patient-centered outcomes evaluated through the “What Matters Most” (WMM) framework were observed. Spectris participants showed significantly less decline in 12 of 41 WMM items, including independence and daily activities, communication, thought processing, emotional stability, and engaging in social activities. The WMM total scores were –0.59 for Spectris vs. –15.12 for sham (p=0.0006), highlighting meaningful impact for participants in their treatment goals.
Spectris is a non-invasive, at-home device used for an hour a day, that uses synchronized light and sound sensory stimulation to evoke brain gamma oscillations. Data presented at AAIC 2025 showed that combining light and sound stimulation generates stronger gamma oscillations across more brain regions than either light or sound alone. Data presented at AAIC 2025 also showed that Spectris had more than 85% of participants adhering to the daily sessions.
Cognito also highlighted its collaboration with Firefly Neuroscience, which is analyzing EEG data from OVERTURE using Firefly’s Brain Network Analytics (BNA™) platform. This partnership aims to identify neurophysiological biomarkers that:
- Predict individual patient response to Spectris treatment
- Monitor longitudinal changes in brain network activity and correlate with functional and cognitive outcomes such as ADCS-ADL and MMSE as well as imaging outcomes with MRI
“The new findings presented at AAIC reinforce the potential of Spectris to not only slow cognitive and functional decline, but to provide meaningful structural preservation that could shift the treatment paradigm in Alzheimer’s,” said Christian Howell, Chief Executive Officer, Cognito Therapeutics. “We believe the future of Alzheimer’s care lies in safe, effective neuromodulation that is grounded in both biology and real-world usability.”
“We’re now seeing consistent outcomes with Spectris across clinical, imaging, and patient-centered domains,” said Ralph Kern, M.D., MHSc, Chief Medical Officer, Cognito Therapeutics. “These findings deepen our understanding of Spectris’ neuroprotective mechanisms and further support our path toward regulatory engagement.”
Spectris™ is currently being evaluated in the fully-enrolled HOPE pivotal clinical trial (NCT05637801) for Alzheimer’s disease. It is an investigational device and has not yet received regulatory approval for commercial use from the U.S. Food and Drug Administration or any other health authority.
About Cognito Therapeutics
Cognito Therapeutics is a late clinical-stage medical device company pioneering neuroprotective therapies to address the unmet needs of patients living with CNS disorders. Its lead product, Spectris™ AD, is an at-home therapeutic device that uses non-invasive, sensory-driven neurostimulation to evoke gamma frequency brain activity. The company’s feasibility studies have shown the potential for Spectris AD to preserve cognition, daily function, and slow brain atrophy in patients diagnosed with mild-to-moderate AD. Cognito is headquartered in Cambridge, MA. For more information, visit www.cognitotx.com and follow @cognitotx.
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