FDA Approves Cognigram Cognitive Assessment Device for Marketing in US

The U.S. Food and Drug Administration (FDA) has approved the marketing of Cognigram, a medical device developed by the cognitive science company Cogstate to evaluate a patient’s cognitive health.

This device may be a useful tool for patients with diseases whose progression is accompanied by cognitive decline, such as multiple sclerosis, mild cognitive impairment, Alzheimer’s disease, HIV-related dementia, schizophrenia, attention deficit hyperactivity disorder (ADHD), and Parkinson’s disease, among others.

Cognigram is a digital battery of tests for cognitive function that can detect even subtle changes that may occur during the early stages of cognitive decline. The device can be used to evaluate cognition once or the level of cognitive change over periodic assessments.

It can be administered by physicians in a clinic or by the patient at home, and its performance is independent of language, education, practice, or cultural background. It is suitable for use between the ages of 6 and 99.

Patients are sent to a local testing center after referral from a doctor. Information about testing centers and a preview of the test are available here.

“After more than fifteen years of intense efforts in supporting academic research and pharmaceutical clinical trials around the world, Cogstate is excited to enter the U.S. market for cognitive assessment on the front lines of clinical practice,” Frank Cheng, Cogstate’s president, said in a news release. “We look forward to bringing the proven and widely-published Cognigram technology into the healthcare ecosystem to benefit an exponentially larger pool of patients.”

In patients with multiple sclerosis, signs of cognitive decline may start early in disease progression and worsen over time. According to the National Multiple Sclerosis Society, this condition may affect patients with different MS courses, but it is slightly more likely in patients with progressive MS.

The brain areas that are most frequently impaired are associated with attention, memory, the speed at which a person processes information, and executive function skills such as planning and prioritizing. People with impaired executive function skills have difficulty engaging in day-to-day activities and have decreased quality of life.