CAMBRIDGE, Mass.--(BUSINESS WIRE)--Cognito Therapeutics, a leader in technology-based therapeutic interventions for neurodegenerative diseases, today announced results from the OVERTURE I study (NCT03556280) which showed that Spectris AD™ significantly slowed the decline in daily functioning and cognitive abilities over six months compared to sham treatment in participants with Alzheimer’s Disease (AD).
Spectris AD™ provided 60-84% more time where participants maintained their functional and cognitive abilities compared to sham treatment, which is a major benefit for people with Alzheimer's and their caregivers. The time savings observed with Spectris AD™ in OVERTURE suggested that study participants continued to live more independently and maintained their quality of life for a longer period of time. These promising results will be evaluated further in the ongoing pivotal HOPE trial (NCT05637801) evaluating Spectris™ in mild to moderate AD.
“This new post hoc analysis from our OVERTURE I study highlight Spectris’ ability to significantly slow the decline in daily function and cognition in patients with Alzheimer’s, potentially offering patients more time to maintain their independence and quality of life,” said Ralph Kern, M.D., MHSc, Chief Medical Officer, Cognito Therapeutics. “These results reinforce our commitment to bring a novel disease-modifying therapy to patients, as we continue to enroll patients in our HOPE pivotal trial.”
The OVERTURE I randomized controlled trial evaluated Spectris in mild-moderate AD. Composite outcome measures, such as CST and iADRS, combine the joint evolution of function and cognition over time in the population of interest when calculating the combined treatment effect. Time savings is an important measure of clinical meaningfulness in AD clinical trials that is gaining increasing attention. Time savings comparing active vs. sham treatment were estimated using ADCS-ADL, MMSE, iADRS and CST outcomes using data obtained in the OVERTURE I study.
Cognito is making three additional presentations at the Alzheimer's Association International Conference 2024 demonstrating the consistency of treatment-related reduction in brain volume loss across baseline subgroups (age, Alzheimer’s disease stage, APOE4 carrier status and baseline PET amyloid) in OVERTURE I as well as data demonstrating the effect of treatment on cerebrospinal fluid proteins related to myelination, synaptic and neuroimmune functions in the 8 week FLICKER study, providing additional key insights into Spectris’ mechanism of action. Mihaly Hajos, PharmD, PhD, Chief Scientific Officer, Cognito Therapeutics will give a presentation entitled “Evoked Gamma Oscillation (Spectris™) as a Potential Therapeutic Intervention for Alzheimer’s Disease” at the ISTAART Electrophysiology Interest Area meeting.
In the OVERTURE I study, 135 participants were screened, 74 were randomized and 53 completed (20 sham, 33 active) the study. Safety, tolerability and adherence were confirmed, and no serious treatment-related adverse events or ARIA were observed. Active versus sham treatment resulted in significant reductions in disease progression over 6 months of treatment as measured by MMSE, ADCS-ADL and MRI measures of brain atrophy (Hajos et al., 2024; Da et al., 2024).
The OVERTURE Phase 2 study MRI outcomes also demonstrated that six months of non-invasive gamma sensory stimulation may reduce the progression of corpus callosum atrophy in individuals with mild-moderate AD, potentially preserving the integrity of a brain structure that supports interhemispheric communication. Cognito is currently enrolling patients in the HOPE pivotal clinical trial to evaluate the efficacy and safety of Spectris as a potential disease-modifying therapy for AD.
The HOPE Study is a randomized pivotal trial investigating the safety and efficacy of Cognito's treatment in mild-to-moderate AD. For more information, visit www.hopestudyforad.com.
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 AD™, 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.
