CAMBRIDGE, Mass.--(BUSINESS WIRE)--Cognito Therapeutics, a neurotechnology company advancing disease-modifying therapies to treat CNS diseases, presented new data today at the 17th Clinical Trials on Alzheimer’s Disease (CTAD) conference demonstrating that Spectris™, a disease-modifying treatment, significantly reduced the Alzheimer’s Disease Dependence Score in patients with mild to moderate Alzheimer’s disease. The findings were reported from the Phase 2 OVERTURE study, which highlights the potential of Spectris™ in improving patient outcomes and reducing caregiver burden.
The Alzheimer’s Disease Dependence Score is a 13-item scale directly derived from ADCS-ADL data and is used to evaluate the required amount of assistance from others that a patient with AD needs due to disease progression. It correlates with cognitive decline as measured by MMSE, caregiver burden and healthcare costs.
The OVERTURE trial (NCT03556280) evaluated the effectiveness of Spectris™ in a randomized controlled setting, followed by a 12-month open-label extension study. The study included 44 participants who completed the initial trial, with 39 participants evaluated at 9 months and 22 at 18 months. The analysis demonstrated a 56.4% lower AD Dependence Score in the active compared to the sham group, estimated over 18 months (p=0.0396).
“Spectris demonstrates a meaningful reduction in dependence associated with Alzheimer’s disease, which not only reflects improved patient function but may also translate to decreased healthcare costs and caregiver time,” said Marwan Sabbagh, M.D., a neurologist in the Alzheimer's and Memory Disorders Program at Barrow Neurological Institute. “The findings affirm our commitment to developing therapies that address the needs of patients and their families.”
Key Findings from the OVERTURE Study:
- Significant Reduction in Alzheimer’s Dependence Score: At 18 months, participants in the active treatment group exhibited an estimated change from baseline of +0.96 (95% CI: 0.47–1.44) compared to +2.20 (95% CI: 1.17–3.24) in the sham group (p=0.0396).
- Strong Safety Profile: No cases of ARIA (Amyloid Related Imaging Abnormalities) were reported, and no serious treatment-related adverse events occurred during the open-label extension study.
Cognito Therapeutics also highlighted the importance of diversity in clinical trials during the presentation of the ongoing Phase 3 HOPE study (NCT05637801). The HOPE study has made significant strides in enrolling a participant population that reflects the real-world demographics of Alzheimer’s disease patients. The interim baseline analysis of 467 participants was composed of 88.7% White, 9.0% Black or African-American, 1.7% Asian, and 0.6% Other/Unknown, with 5.6% identifying as Hispanic or Latino.
“Diversity in clinical trials is crucial for the development of therapies that can be generalized across representative patient populations,” said Ralph Kern, M.D., MHSc, Chief Medical Officer, Cognito Therapeutics. “Our collaboration with the Global Alzheimer’s Platform Foundation (GAP) has enabled us to implement targeted recruitment strategies to enhance participation of underrepresented groups.”
The study utilized a collaboration with GAP to geographically select diverse study sites and implement Diversity, Equity, and Inclusion training for site staff, ensuring culturally competent outreach to diverse communities. The HOPE study demographics are reflective of current US Alzheimer’s disease populations. The patient demographics in the HOPE study demonstrate that the methods utilized in this study highlight the benefits of targeted site selection and tailored recruitment efforts in diverse communities.
Cognito Therapeutics is currently enrolling patients in the ongoing HOPE pivotal trial. For more information visit www.hopestudyforad.com.
About Cognito Therapeutics
Cognito Therapeutics is a late-stage clinical neurotechnology company pioneering disease-modifying treatments for neurodegenerative diseases. Its lead product, Spectris™, uses non-invasive auditory and visual neuromodulation to enhance gamma frequency brain activity, with the goal of slowing brain atrophy and functional decline in Alzheimer's disease. Cognito is committed to developing transformative, technology-driven interventions to address unmet needs in the treatment of CNS diseases. Cognito is headquartered in Cambridge, MA. For more information, visit www.cognitotx.com and follow @cognitotx.
