IntellexxDNA has been cleared by the US Institutional Review Board (IRB) to start a study for its clinical decision support (CDS) tool.

The “GPS-MEM Study: A Precision Study of Memory” study will evaluate the efficacy of IntellexxDNA’s CDS tool in aiding the physician’s decision-making process in managing patients with neurodegenerative diseases such as Alzheimer’s disease and other forms of dementia.

The CDS tool identifies the modifiable factors that contribute to cognitive decline and other potentially related chronic conditions. It then helps physicians to develop a genomically targeted personalised plan to address these factors.

“The fusion of genomics and clinical decision-making offers a frontier of hope. With the GPS-MEM study, we’re not just observing, we’re aiming to change the narrative of cognitive health,” said Dr Sharon Hausman-Cohen, IntellexxDNA’s medical director.

“Our deep genetic insights paired with actionable intervention strategies have the potential to redefine memory care.”

GlobalData predicts the Alzheimer’s disease drug market to be worth $12.9bn in 2028 across the eight major markets (US, Germany, France, Italy, Spain, UK, Japan, and China). This growth in part will be fuelled by the increased diagnosis of the disease, making dementia management a lucrative field.

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Study design

The trial is expected to enrol up to 20 patients aged 50 to 85 years, with dementia, mild cognitive impairment or subjective cognitive impairment. The trial will also enrol patients with a baseline Mini-Mental State Examination (MMSE) score of 24-30, indicating possible cognitive impairment.

Investigators will track participants’ Clinical Dementia Rating-Sum of Boxes (CDR-SB) global score, and central nervous system (CNS) vital memory signs.

The study’s secondary objective is to determine the proportion of individuals benefiting from IntellexxDNA’s CDS tool and assess typical improvements in cognitive outcomes.