Drug Development

In the field of Alzheimer’s disease (AD) and related disorders, the recent research focus has shifted toward identifying and treating subjects in the preclinical stages of disease progression. This is consistent with efforts to identify the earliest opportunity when intervention may be effective and prevention may be possible. However, this shift has required a new paradigm for evaluating cognition and for analyzing neuropsycholgical assessment data, especially in clinical trials.

While existing cognitive assessment batteries capture a vast amount and a robust quality of data, the standard methods for modeling the data and isolating signals have been fairly rudimentary. Even recent efforts to develop weighted composite measures largely ignore the wealth of information contained in the data collected by most common batteries. The FDA has been clear in its most recent guidance to drug developers in the AD field; they are open to innovative and sophisticated approaches to more precise characterization of cognition. Embic’s quantified cognitive processes (qCPs) provide such precise characterization and can facilitate faster, more effective enrollment of pre-clinical AD subjects while capturing subtle treatment effects that might discriminate between treatment and placebo effects.

Embic’s qCPs are derived from models that use item-level and response pattern data from well-validated neuropsychological batteries. These biomarkers enable:

• Quantification of unobservable cognitive processes that are affected even when cognitive symptoms are too subtle to detect
• Prediction of impending cognitive decline due to AD, in cognitively normal subjects, using only baseline cognitive assessment data from a brief battery
• Prediction of likelihood of underlying AD biomarkers (e.g., PET/CSF amyloid, tau) using only baseline cognitive assessment data from a brief battery

The availability of Embic’s qCPs will improve the AD clinical trial process by:

• Accurately and pragmatically identifying trial candidates in preclinical or early stages of AD
• Inexpensively and non-invasively classifying subjects with high likelihood to meet enrollment criteria, prior to expensive or invasive evaluation (e.g., PET, CSF)
• Quantifying subtle, but theoretically well-grounded changes in cognitive outcome measures

Embic’s qCPs stand to accelerate trial enrollment with well-qualified, accurately diagnosed subjects who were identified more quickly, with lower screen fail rates, and lower enrollment costs. Once trials are enrolled, Embic’s biomarkers can demonstrate meaningful treatment effects on underlying cognitive processes that are clear indicators of disease progression.