“We are excited by the results we presented today as they further validate our platform and its potential to significantly decrease the time spent running clinical trials in an area of significant patient need like Alzheimer’s disease,” said Charles K. Fisher, Ph.D., founder and CEO of Unlearn.AI. “Drug development in Alzheimer’s disease is increasingly expensive and time consuming. We believe that our platform can help alleviate these burdens and accelerate clinical trials to help get new medicines to the patients who need them.”
Unlearn is addressing patient recruitment, one of the biggest challenges associated with Alzheimer’s disease clinical trials, through its machine learning-based model that incorporates Digital Twins into Intelligent Control Arms of clinical studies. A Digital Twin is a comprehensive, longitudinal and computationally generated clinical record that describes what would have happened if a specific patient had received a placebo. The proprietary DiGenesis™ process leverages historical clinical trial datasets from thousands of patients, disease-specific machine learning models and rigorous statistical analysis to create digital records that are perfectly matched to patients in the investigational-treatment arm of studies.
To obtain a large and diverse sample of control data for its Alzheimer’s disease model, Unlearn utilized records through its membership with Critical Path for Alzheimer’s Disease (CPAD) from 5,000 people with early to moderate Alzheimer’s disease from the control arms of 16 historical clinical trials. The model captured the relationship between 50 clinical variables relevant to Alzheimer’s disease, such as components of neurologic exams, over 18 months to track the progression of the disease
“The current state of clinical trials is challenging, especially for debilitating diseases like Alzheimer’s where patient recruitment is especially difficult,” said Marina Brodsky, Ph.D., former vice president, therapeutic area head, pain and neuroscience, medical affairs at Pfizer. “I am encouraged by these findings and see strong potential in the Unlearn platform to change the way we populate control arms for clinical trials, dramatically reducing time to bring them sooner to patients who desperately need them.”