Reviewing the Phase 2 OVERTURE Results of Gamma Sensory Stimulation Device: Brent Vaughan

WATCH TIME: 4 minutes

"The other quite unique thing to our data, besides the safety profile, is that our mechanism of action focuses on preserving the structure and volume of the brain. Patients with Alzheimer disease and some other neurodegenerative diseases have accelerated brain atrophy. We showed a 69% slowing of brain atrophy."

Alzheimer disease (AD), the most common form of dementia, is characterized by a general cognitive decline that typically begins with episodic memory impairment and loss of functional independence. The treatment landscape for the disease is limited, although several agents in the pipeline hold promise with potential disease-modifying effects. Noninvasive brain stimulation, including multisensory stimulation targeting the restoration of abnormal brain oscillations, has been proposed as an alternative therapeutic strategy.

At the 2023 Clinical Trials on Alzheimer’s Disease (CTAD) conference, held October 24-27, in Boston, Massachusetts, new 18-month data were presented from the phase 2 OVERTURE study (NCT03556280), a pivotal trial assessing the efficacy and safety of a gamma sensory stimulation device (Cognito Therapeutics) in patients with mild to moderate AD. The analysis included participants who completed the 6-month randomized controlled portion who continued on to receive 1-hour daily treatment for an additional 12 months in the open-label extension. In addition to observing safety and efficacy, the trial also used MRI historical controls from the Alzheimer’s Disease Neuroimaging Initiative to compare whole brain volume changes.

Brent Vaughan, chief executive officer of Cognito Therapeutics, sat down with NeurologyLive® at the conference to discuss the results in detail, outlining the most critical findings clinicians should key in on. He spoke on the drug’s safety, efficacy, and impact on brain volume, as well as how the data builds on previously announced 6-month findings presented at the 2022 American Academy of Neurology annual meeting.

Click here for more coverage of CTAD 2023.

REFERENCE
1. Kuang C, Hajos H, Konisky A, et al. OVERTURE open-label extension data confirms safety, adherence, and durability of treatment benefits over 18 months. Presented at: Clinical Trials on Alzheimer’s Disease conference; October 24-27, 2023; POSTER LP026