22 February 2023 - - The first patient enrollment in US-based clinical-stage neurotechnology company Cognito Therapeutics' US pivotal study, designed to demonstrate the safety and efficacy of its proprietary non-invasive stimulation device CogTx-001 in patients with Alzheimer's Disease, the company said.

The Alzheimer's Association estimates that more than 6m people in the US are living with Alzheimer's disease.

The impact of this devastating disease is immeasurable for individuals and their families around the world.

Currently there are only a few FDA approved medications that may help manage symptoms, but none are able to significantly slow or stop disease progression.

Fortunately, science is racing towards new methods of prevention and treatment.

The HOPE Study for Alzheimer's Disease evaluates a novel wearable device developed by Cognito Therapeutics, with the potential to slow the progression of Alzheimer's disease, without the safety concerns associated with medications or highly invasive procedures.

In the blinded sham-controlled study, 400 patients with Alzheimer's disease will use Cognito's proprietary non-invasive wearable device at home on a daily basis for 12 months.

Cognito's device has been evaluated in multiple clinical studies for safely and effectively delivering specific frequencies of targeted light and sound-based stimulation.

In the OVERTURE study, patients using the Cognito wearable device reported a reduction in disease progression by 83% as measured by the Mini-Mental State Exam and 78% as measured by the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL).

A significant reduction of brain atrophy and preservation of white matter was also reported in patients using the Cognito device over a 6-month period.

The 12-month HOPE study is designed to build upon the success of the OVERTURE study by demonstrating both slowing of disease progression as measured by the primary endpoints of the ADCS-ADL and a combined statistical test of the ADCS-ADL and the MMSE as well as slowing of brain atrophy as measured by MRI.

The study is also designed to include assessment of secondary endpoints including change from baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB).

Cognito's device is limited by United States law to investigational use only and is not available for sale.

Cognito Therapeutics is advancing the field of neuromodulation by pioneering non-invasive sensory stimulation therapy that improves the lives of patients living with neurodegenerative diseases.

Since 2016, the company has been developing optogenetics-based disease-modifying solutions utilizing proprietary light and sound stimulation that have shown to preserve cognition and brain structure by slowing white matter loss seen with Alzheimer's Disease.

The company's lead neuromodulation system received FDA Breakthrough Device Designation in 2020 and is currently in a pivotal US study named HOPE. The technology has been published in Nature, Neurology and Cell. Cognito Therapeutics is based in Cambridge, MA.