[April 15, 2024]

Cognito Therapeutics Announces Spectris™ Demonstrates Durable Effects on Activities of Daily Living in the OVERTURE II Study

Cognito Therapeutics, a leader in technology-based therapeutic interventions for neurodegenerative diseases, announced today treatment results from OVERTURE II, an open-label extension (OLE) study of Spectris™, a potential disease modifying therapy for the treatment of Alzheimer's Disease. The results were presented at the 2024 American Academy of Neurology in Denver, CO.

OVERTURE II was a separate 12-month OLE protocol that followed the six-month OVERTURE I randomized clinical trial (RCT), in which 83% of OVERTURE I study participants enrolled. OVERTURE I results have recently been published in the peer-reviewed journal Frontiers in Neurology. OVERTURE II enabled the evaluation of extended Spectris™ treatment over 18 months, employing a delayed-start analysis to evaluate the potential of Spectris™ as a disease modifying therapy. Spectris™ uses proprietary light and sound stimulation to evoke EEG-confirmed gamm frequency brain oscillations.

"Clinical studies to date with Spectris™ have demonstrated high levels of adherence among patients, while also showing the potential of Spectris™ as a disease modifying therapy," said Ralph Kern, M.D., MHSc, Chief Medical Officer of Cognito Therapeutics. "This innovative therapy has the potential to be seamlessly integrated as a home-based treatment into the lives of patients and caregivers."

Statistically significant separation of activities of daily living (ADCS-ADL total score) between active and sham treatment groups was observed at the end of OVERTURE I (p=0.0006), which was maintained after 12 months of treatment in OVERTURE II (p=0.0045). There was no observed convergence of ADCS-ADL scores between early and delayed start groups in OVERTURE II.

Participants receiving sham device treatment in OVERTURE I who switched to active device treatment (delayed start) in OVERTURE II demonstrated a similar rate of decline of ADCS-ADL and whole brain volume compared with continued active treatment (early start) but the delayed treatment group did not catch up to the early treatment group. These results suggest that combined OVERTURE I and II treatment outcomes with the Spectris™ device are consistent with published criteria for disease modification and support early treatment.

No cases of ARIA or serious treatment-related adverse events were reported over 12 months in the 44-patient OVERTURE II study. High device adherence (80%) was reported in OVERTURE II, which was comparable to that observed in OVERTURE I.

About Cognito Therapeutics

Cognito Therapeutics is a late clinical-stage neurotechnology company dedicated to the development of transformative disease-modifying therapies for neurodegenerative diseases. Cognito's proprietary approach targets dysregulated network activity in the brain and has shown meaningful outcomes in Alzheimer's patients. Cognito's lead product, Spectris, employs a proprietary non-invasive method designed to evoke increased gamma frequency brain activity using auditory and visual neuromodulation to slow the rate of brain atrophy and loss of brain function. Cognito's mission is to develop a new class of technology-based therapeutic interventions to transform the lives of patients with neurodegenerative diseases. Cognito is headquartered in Cambridge, MA. For more information, visit www.cognitotx.com.

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