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SAGE Test Detects Early Dementia At Least 6 Months Sooner Than MMSE

SAP Partner | <b>The Ohio State University- Wexner Medical Center</b>

Investigators also pointed to the potential repetitive administration of the SAGE test to identify stability or decline, effectively providing an objective cognitive biomarker.

The Self-Administered Gerocognitive Examination (SAGE) test was evaluated in a recent longitudinal study, with investigators concluding the assessment identified mild cognitive impairment (MCI) conversion to dementia at least 6 months ahead of the non-self-administered Mini-Mental State Examination (MMES) in 5 different diagnostic subgroups.1

The study included a total of 424 patients, 40 of whom had subjective cognitive decline (SCD), 94 of whom were MCI nonconverters to dementia, 70 of whom were MCI converters to dementia, and 220 of whom had AD dementia. Of the MCI converters to dementia, 49 converted to Alzheimer disease (AD) dementia and 21 progressed to non-AD dementia.

The SAGE test showed a statistically significant decline from baseline scores at least 6 months ahead of the MMSE for patients who converted from MCI to AD dementia (14.4 vs 20.4 months), patients who converted from MCI to non-AD dementia (14.4 vs 32.9 months), and patients with AD dementia (8.3 vs 14.4 months). When looking at annual SAGE and MMSE scores, MCI converters to dementia declined at rates of 1.91 points per year (P <.0001) and 1.68 points per year (P <.0001), respectively. For those with AD dementia, SAGE and MMSE scores declined at rates of 1.82 points per year (P <.0001) and 2.38 points per year (P <.0001), respectively. Scores were stable for patients who with SCD and MCI nonconverters. 

The patients that were identified as being likely to eventually develop dementia had a 2- to 3-point decline in SAGE scores 12-18 months from baseline, which was a significant decline, lead author Douglas Scharre, MD, director, Division of Cognitive and Memory Disorders, department of neurology, the Ohio State Wexner Medical Center, told NeurologyLive®.

“It gave a little hint that this is the time to maybe think about diagnosis—if you're in a [primary care provider’s] office, especially—maybe we can get more supervision for them, maybe we can start doing Power of Attorney, maybe watch their driving, check their medications,” Scharre said. “If they're early on for Alzheimer's, all the medications that we know for Alzheimer's—or for most cognitive conditions—will work better the earlier you start… [the SAGE test] was designed to be an effective screening tool to identify people, start treatments early, and typically lead to better results.”

READ MORE: The Promise the Alzheimer Disease Pipeline Holds Heading Into 2022

Annual rates of change were originally performed on 665 consecutive patients from the Ohio State University Memory Disorders Clinic, and patients with at least 3 visits 6 months apart were evaluated with both assessments. Taking between 10 to 15 minutes to complete, the SAGE test is a pen-and-paper assessment, with a digital companion test, the BrainTest, which can be performed on a tablet or touchscreen computer.

“[The SAGE test] is a way to be able to identify and recruit more easily for mild cognitive impairment. With the digital test, it’s even easier because you could actually do it at home, you could submit it, and it's automatically graded, so that sponsors may know sort of where they are,” Scharre said. “It’s not a perfect test, but it really narrows down and gets rid of the people that are doing perfectly well that probably aren't qualifying [and] the people that are in the dementia classification, which usually are also are not qualified.”

Investigators noted the single-site cohort study was limited due to imitations were identified as potential referral and sampling biases. As both the SAGE and MMSE were given in a clinical setting, the results cannot be generalized to the SAGE test being given remotely and then compared to the MMSE. The SAGE test itself also has specific limitations because of the fact that self-administered assessments of memory abilities are inherently challenging. 

The SAGE test is not the only test currently being developed as a computerized cognitive assessment for studies into dementias. In November 2021, Cognetivity Neurosciences announced their Integrated Cognitive Assessment, the CognICA, had met the requirements of regulations as a Class II Exempt Medical Device following review by the FDA. The system is powered by artificial intelligence and delivered via iPad devices, taking patients approximately 5 minutes to complete.2 

To learn more about the device and its application, we sat down with Chris Kalafatis, MD, MRCPsych, chief medical officer at Cognetivity. Hear what he had to say about the CognICA’s potential in the video below. 

REFERENCES
1. Scharre DW, Chang S, Nagaraja HN, Wheeler NC, Kataki M. Self-Administered Gerocognitive Examination: longitudinal cohort testing for the early detection of dementia conversion. Alzheimers Res Ther. 2021;13(1):192. doi:10.1186/s13195-021-00930-4
2. Cognetivity Neurosciences granted FDA clearance for commercial distribution of ICA throughout US healthcare market. News release. Cognetivity Neurosciences. October 20, 2021. Accessed January 5, 2021. https://cognetivity.com/cognetivity-neurosciences-granted-fda-clearance-for-commercial-distribution-of-ica-throughout-us-healthcare-market/