Alzheimer’s Research & Therapy:
Linus Health Digital Clock and Recall Test Detects Early Cognitive Impairment in Over 80% of Patients Who Were Misclassified in Commonly Used Paper-Based Test


Study published in peer-reviewed journal demonstrates superior sensitivity and accuracy of Linus Health’s digital cognitive assessment over the Mini-Mental State Examination

A proprietary cognitive assessment from Linus Health, a digital health company focused on enabling early detection of Alzheimer’s and other dementias, outperforms the most commonly used paper-based assessment in detecting early mild cognitive impairment and dementia and with less ethnic and racial bias, according to a peer-reviewed study recently published in the prestigious medical journal Alzheimer’s Research & Therapy.

The article, “Digital Clock and Recall is superior to the Mini‑Mental State Examination (MMSE) for the detection of mild cognitive impairment and mild dementia,” is the latest addition to more than 20 other studies published in peer-reviewed scientific journals validating the Linus Health Digital Clock and Recall (DCR™) assessment within its Core Cognitive Evaluation (CCE™) solution. The body of research confirms the most recent findings that the DCR outperforms a commonly used traditional cognitive test, the MMSE, in detecting early signs of cognitive impairment, and is more accurate overall in classifying mild cognitive impairment and mild dementia.

“The evidence continues to accumulate that DCR is a quick, sensitive, and accurate assessment for identifying cognitive impairment and is superior in those aspects to traditional cognitive screening tests,” said the study’s lead author Ali Jannati, MD, PhD, Director of Cognitive Science at Linus Health. “As the centerpiece of our CCE solution, the DCR offers an abundance of data that our machine-learning algorithm uses to assess a patient’s level of cognitive functioning in various domains, as well as forecast the future risk of developing dementia and recommend the types of diagnostic and therapeutic steps that would be the most appropriate to that patient.”

More than 80% of Americans are unfamiliar with mild cognitive impairment, which can be an early stage of Alzheimer’s Disease, according to the Alzheimer’s Association. Symptoms are also not always noticeable, leading to delayed screenings and potentially greater risk to patients’ brain health.

“Screening early for mild cognitive impairment is essential, since earlier lifestyle and pharmacologic interventions have been demonstrated to prevent progression of the condition and brain-related disabilities,” said Linus Health Chief Medical Officer and Co-Founder Alvaro Pascual-Leone, MD, PhD. “We’ve shown in this study that the DCR can facilitate more of those early screenings across a wider population because they can be completed quickly and easily and results are immediate so that patients are empowered to begin their care journey as soon as possible.”

A clinical research team from Linus Health led the study that compared cognitive classifications by the DCR, which is a less than three-minute test given by a medical assistant or provider with an Apple iPad and Apple Pencil, and the MMSE, the older, more commonly performed test, typically taking 10 to 20 minutes to complete by older adults and requiring trained personnel for accurate administration.

Researchers studied a population of 706 participants with an average age of 71 years old, 59% of whom were women and 85% of whom were white. Participants performed neuropsychological tests, including the MMSE and the Rey Auditory Verbal Learning Test (a gold standard test for assessing verbal memory), and were evaluated by clinicians. Each participant also took the DCR, a self-administered, supervised digital cognitive assessment composed of drawing a clock face at a specific instructed time and then copying from a clock template. The test also included an immediate and delayed recall of three words. Participants completed the DCR in approximately 3 minutes while, in the same population, the MMSE took 7 minutes on average.

Results showed that the DCR had greater sensitivity and accuracy than the MMSE for detecting and classifying cognitive impairment. In fact, the authors calculated that relying on the MMSE for cognitive screening could result in missing nearly one-third (32%) of patients at earlier stages of amnestic cognitive impairment, for whom initiating treatment and behavioral interventions hold the most promise. In contrast, the DCR was able to detect cognitive impairment in more than 80% of those the MMSE misclassified.

The results also showed that, unlike the MMSE, the DCR is not influenced by ethnicity, indicating its ability to increase care equity and reduce health disparities among ethnic minorities who are at increased risk of dementia. Moreover, the DCR enables administration in a variety of languages, thus allowing clinicians to better serve a diverse population.

These high levels of sensitivity and accuracy are feasible because the DCR analyzes upwards of 500 metrics captured during the process of clock drawing within 3 minutes. The solution can detect subtle signals during test performance, such as variations in Apple Pencil movement, pressure on the screen, placement of numbers, how the circle is drawn, and other metrics relevant to various cognitive domains.

“The DCR offers evidence-based insights in less time to help busy primary care providers manage patients using an effective, objectively scored, efficient, and scalable digital tool,” said Dr. Jannati.