- 65% reduction of whole brain atrophy (brain volume loss) associated with Alzheimer’s progression by gamma frequency neuro-modulation in Alzheimer’s Disease patients

- Gamma frequency neuro-modulation treatment maintained functional ability and decreased sleep fragmentation in Alzheimer’s Disease patients

Cognito Therapeutics, a Phase 3-ready neuro-physiology company developing a new class of disease-modifying digital therapeutics to treat neurodegenerative disorders, presented key findings from clinical research involving its lead digital therapeutic candidate at the Alzheimer’s Association International Conference^® 2021 (AAIC^®), virtual and in-person in Denver, Colorado, July 26-30, 2021.

These results, disclosed in 6 poster presentations at AAIC, included data on gamma frequency neuro-modulation on cognitive function in Alzheimer’s Disease (AD), which showed improvements in sleep, improvements in memory and cognition, as well as a reduction in brain atrophy and volumetric loss.

The Phase 2 study OVERTURE (NCT03556280) is a prospective 6-month treatment study in mild-to-moderate AD. In the OVERTURE study, anatomical and structural magnetic resonance imaging (MRI) data were acquired at screening/baseline, 3-months and 6-months using 1.5 Tesla MRI. These imaging data were used for safety monitoring and longitudinal biomarker outcomes including quantification of neurodegeneration via MRI.

The OVERTURE study demonstrated that gamma frequency neuro-modulation led to a significant reduction in brain atrophy in AD patients. Accelerated brain atrophy is associated with cognitive decline and loss of function in AD patients and is a driver of mortality and morbidity in Alzheimer’s disease progression. Over a 6-month treatment period, significant treatment benefits were observed in the active group versus the sham group. The treatment group demonstrated a significant, 65% reduction in Whole Brain Volume loss as compared to the sham group over the same interventional period.

In addition, sleep abnormalities are associated with AD, and there is a strong association between disrupted sleep and the development and progression of AD. Improving sleep is an important aspect of new therapeutic strategies for patients with AD. Gamma frequency neuro-modulation over a 6-month period reduced night-time active durations and maintained day-time activities. Nighttime active durations in the treatment group were significant reduced in the second 3 months compared to the first 3 months but the opposite change was observed in the sham group. The current results demonstrate that a beneficial effect of gamma frequency neuro-modulation in mild-to-moderate AD patients have reducing the active period spent during nighttime sleep.

“Our results presented at AAIC 2021 demonstrate that our unique neurophysiological medicine approach can affect disease modification by improving memory, cognition and functional symptoms while also reducing brain atrophy, the brain volume loss seen with Alzheimer’s progression,” said Brent Vaughan, Chief Executive Officer, Cognito Therapeutics. “The improvements we have now reported in nighttime sleep for patients with Alzheimer’s, provide further support for our mechanism of disease modification in this patient population. This is a significant milestone, and we look forward to expanding upon our clinical validation in our pivotal study in Alzheimer’s disease.”

“We are excited to present this disease-modifying data for the first time, showing that our digital therapeutic reduces loss in brain atrophy, a key driver of disease progression in Alzheimer’s,” said Mihaly Hajos, Ph.D., Chief Scientific Officer, Cognito Therapeutics. “This represents a fundamental shift in towards treating this neurodegenerative disease, and this data provides further confirmation of our unique mechanism of action on neurons in the brain.”

To meet with the Cognito team on-site at AAIC, please contact aaic2021@cognitotx.com.

About Cognito Therapeutics

Cognito Therapeutics is a clinical-stage neuro-physiology company developing a pipeline of disease-modifying digital therapeutics that have clinically demonstrated drug-like effects using gamma frequency neuromodulation to treat neurodegenerative disorders including Alzheimer’s disease. The company’s licensed proprietary gamma frequency neuromodulation platform technology, developed by scientific founders at MIT, Professors Li-Huei Tsai and Ed Boyden is a non-invasive therapy utilizing visual and auditory stimulation to treat neurodegenerative diseases. The company is based in Boston and San Francisco. For more information, please visit www.cognitotx.com. Follow us on Twitter at @cognitotx.

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