Cognito Therapeutics conducting new Alzheimer’s study in Fort Bend

Alzheimer’s is a terrible disease that affects millions of people in the United States every year, according to the Alzheimer’s Association, with no immediate known way to reduce the relentless progression of the disease. But a new study that has been launched and is being conducted in Fort Bend County is trying to show signs of progress when it comes to doing so.

Since February, Cognito Therapeutics, a clinical-stage neurotechnology company, has seen the first patient enrollment in its US pivotal study called HOPE in Fort Bend County. The program is designed to evaluate the safety and efficacy of its proprietary non-invasive sensory stimulation device CogTx-001 in patients with Alzheimer’s disease, according to Cognito.

The clinical study evaluates a 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, Cognito says that at least 400 patients with Alzheimer’s disease were set to use Cognito’s proprietary non-invasive wearable device at home on a daily basis for a year.

“At Cognito we are committed to advancing our personalized targeted medical device technology to address the unmet need in Alzheimer’s disease, using the brain’s electrical activity as a treatment

The Cognito Team

“At Cognito we are committed to advancing our personalized targeted medical device technology to address the unmet need in Alzheimer’s disease, using brain’s electrical activity as a treatment target. We are encouraged by the outcome of our 6-month long phase 2 clinical trial, OVERTURE, that enrolled 73 participants. The trial not only confirmed the safety and tolerability of our non-invasive medical device, but also demonstrated significant stabilization of daily function and cognitive abilities, as well as reduced brain volume loss among those treated by our device.

We are truly excited about the HOPE study, which gives us the opportunity to assess the effectiveness of our medical technology platform in mild to moderate Alzheimer’s disease at over 50 study clinics across the US. We could not do this without the efforts and dedication of those living with Alzheimer’s disease, their care partners, and the dedicated expert professionals.”

- Chief Medical Officer and sponsor of the study, Dr. Ralph Ker target. We are encouraged by the outcome of our six-month long phase 2 clinical trial, OVERTURE, that enrolled 73 participants,” Cognito Chief Medical Officer Dr. Ralph Kern said.

In previous studies, Cognito’s device has been able to effectively deliver specific frequencies of targeted light and soundbased stimulation. In the OVERTURE study, patients using the Cognito device reported a reduction in disease progression by 76 percent as measured by the Mini-Mental State Exam (MMSE) and 77 percent as measured by the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL). A significant reduction of brain atrophy and preservation of brain white matter was also reported in patients using the Cognito device over a six-month period, according to Cognito.

Cognito Therapeutics is attempting to advance 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 leveraged scientific discoveries based on optogenetics to develop disease-modifying solutions utilizing a proprietary light and sound stimulation device technology that has been shown to preserve function, cognition and brain structures in Alzheimer’s Disease.

“The HOPE study offers a rare opportunity for patients with mild to moderate Alzheimer’s disease to participate in a research study utilizing technology as an intervention,” said Michelle Papka, Ph.D., Director and Founder of The Cognitive and Research Center of New

Jersey. “Patients and their family members have expressed great interest in enrolling in this study because it is non-invasive and represents a novel and safe approach to potentially slowing the progression of Alzheimer’s disease.”

“The OVERTURE trial not only demonstrated the safety and tolerability of our non-invasive medical device, but also showed significant stabilization of daily function and cognitive abilities, as well as reduced brain volume loss among those treated by our device,” Kern said.

The 12-month phase 3 HOPE study is designed to build upon the success of the phase 2 OVERTURE study by demonstrating slowing of disease progression as measured by the primary endpoints of the ADCS-ADL, a combined statistical test (CST) of the ADCS-ADL and the MMSE as well as secondary endpoints of MRI brain volume and clinical dementia rating- sum of boxes (CDR-SB).

For more information on the HOPE Study, visit the study’s website at https://www. hopestudyforad.com/.

See our ad on page 24 (the back page) to learn more about this study and information on how to get involved.