Emerging Longitudinal Cognitive Assessment Built on Precision Neurology
Over the last several decades, we have continued to identify modifiable risk factors for neurological disease and have deepened our understanding of how to control and modify these risk factors to reduce the risk of disease development and progression. However, aging—currently regarded as a non-modifiable risk factor—is considered the greatest risk factor for most neurological diseases, including Alzheimer’s disease and Parkinson’s disease.
Worldwide, the aging population is perhaps the largest factor driving increased investment in neuroscience research and neurological disease drug development. The fastest-growing age group in the world is now those aged 65 and over—in the year 1980, this age group accounted for just 5.9% of the global population (262 million individuals); by the year 2040, this age group will account for 14.1% of the global population (1.3 billion individuals).
However, pharmaceutical companies are developing many promising neurological disease-modifying drugs that go beyond treating symptoms, slowing and potentially even halting disease progression. However, the following issues are hindering their ability to bring drugs to market quickly and help neurological disease patients:
Worldwide, the aging population is perhaps the largest factor driving increased investment in neuroscience research and neurological disease drug development. The fastest-growing age group in the world is now those aged 65 and over—in the year 1980, this age group accounted for just 5.9% of the global population (262 million individuals); by the year 2040, this age group will account for 14.1% of the global population (1.3 billion individuals).
However, pharmaceutical companies are developing many promising neurological disease-modifying drugs that go beyond treating symptoms, slowing and potentially even halting disease progression. However, the following issues are hindering their ability to bring drugs to market quickly and help neurological disease patients:
Costly and time-consuming subject screening and selection
Unreliable tools for longitudinal cognitive assessment of trial subjects
Lack of tools to support decentralized clinical trials and remote subject monitoring
Let’s take a deeper look into challenges with traditional longitudinal cognitive assessment tools in clinical trials and how Altoida’s Precision Neurology platform and app-based medical device will bridge the gap to improve and accelerate neurological disease clinical trials, aiding in the effort to bring new treatments to market.
Challenges with Longitudinal Cognitive Assessment Tools in Clinical Trials
The primary downfalls of traditional longitudinal cognitive assessment tools, such as the Mini-Mental State Examination (MMSE), can be seen throughout every stage of neurological disease clinical trials.
Below, we detail some of the top challenges pharmaceutical companies face, including subject screening and selection, subject monitoring and assessment of drug efficacy, and decentralization of clinical trials.
Below, we detail some of the top challenges pharmaceutical companies face, including subject screening and selection, subject monitoring and assessment of drug efficacy, and decentralization of clinical trials.
Screening and Selecting Trial Subjects
Let’s take a deeper look into challenges with traditional longitudinal cognitive assessment tools in clinical trials and how Altoida’s Precision Neurology platform and app-based medical device will bridge the gap to improve and accelerate neurological disease clinical trials, aiding in the effort to bring new treatments to market.
Monitoring Subjects and Assessing Drug Efficacy
Understanding at a highly granular level how an individual’s Activities of Daily Living (ADLs) are changing is arguably the most compelling method for monitoring brain function in neurological disease patients. However, longitudinally assessing the effects of neurological disease-modifying drugs on clinical trial subjects is currently largely dependent on costly imaging and outdated, unreliable longitudinal cognitive assessment tools.
Whether done via pencil and paper or digitally, these assessments are based on non-ecologically valid testing methods, meaning the design of the evaluation does not align with neurocognitive states representative of ADLs. They collect limited data on cognition and practically no data on function; as a result, they do not produce sufficient evidence to conclude precisely how a drug is impacting both cognition and function at the granular level necessary to prove drug efficacy. The lack of reliable data produced from traditional assessments can also significantly delay go/no-go decisions, wasting valuable time, money, and resources.
Additionally, these cognitive assessment tools must be administered by a human, making them subject to bias. This limited, non-generalizable, and potentially biased data leads to noisy and inaccurate measurements in longitudinal settings as well as poor diagnostics accuracy.
Whether done via pencil and paper or digitally, these assessments are based on non-ecologically valid testing methods, meaning the design of the evaluation does not align with neurocognitive states representative of ADLs. They collect limited data on cognition and practically no data on function; as a result, they do not produce sufficient evidence to conclude precisely how a drug is impacting both cognition and function at the granular level necessary to prove drug efficacy. The lack of reliable data produced from traditional assessments can also significantly delay go/no-go decisions, wasting valuable time, money, and resources.
Additionally, these cognitive assessment tools must be administered by a human, making them subject to bias. This limited, non-generalizable, and potentially biased data leads to noisy and inaccurate measurements in longitudinal settings as well as poor diagnostics accuracy.
Running and Managing Decentralized Clinical Trials
The COVID-19 pandemic has catalyzed the adoption of decentralized clinical trials while showcasing the important benefits of virtual trials and the potential to improve the patient and physician experience. However, traditional longitudinal cognitive assessment tools require in-person administration, either at a clinical site or another clinical environment, as well as the use of human scoring. These assessments are simply not built to support decentralized trials or remote monitoring of subjects.
The Shift Towards Digitized Cognitive Assessments Isn’t Enough
Over the past 10 years, we have seen an increase in the use of digitized cognitive assessments in neurological disease clinical trials—while this does offer ease of assessment deployment and the ability to remotely monitor subjects, these assessments still rely on the same non-ecologically valid, narrow-natured, and unreliable approach to assessing brain function.
The First of Its Kind: A Longitudinal Cognitive Assessment Built on Precision Neurology
At Altoida, we are building the world’s-first Precision Neurology platform and app-based medical device—backed by 11 years of clinical validation—to accelerate and improve drug development, neurological disease research, and patient care.
By completing a series of augmented reality and motor activities designed to simulate complex ADLs on a smartphone or tablet, Altoida’s device extracts and provides new and robust measurements of neurocognitive function across 13 unique neurocognitive domains:
By completing a series of augmented reality and motor activities designed to simulate complex ADLs on a smartphone or tablet, Altoida’s device extracts and provides new and robust measurements of neurocognitive function across 13 unique neurocognitive domains:
Perceptual-motor coordination
Complex attention
Inhibition
Flexibility
Visual perception
Planning
Prospective memory
Spatial memory
Cognitive processing speed
Eye movement
Speech and articulation
Fine motor coordination
Gait
How Does It Work?
Our device measures and analyzes nearly 800 multimodal cognitive and functional active digital biomarkers. Through the collection of highly granular data from integrated smartphone or tablet sensors, Altoida’s device produces comprehensive neurocognitive domain scores.
Our web-based platform allows clinical stakeholders to manage and monitor populations. Subject data from Altoida’s tests and other health data, such as prescriptions, traditional biomarker data, and existing conditions, will be available in the platform and can be observed longitudinally to reveal trends and patterns.
When paired with our innovative artificial intelligence, this method will pioneer fully digital predictive neurological disease diagnosis. After our recent Breakthrough Device designation by the FDA, Altoida’s device will provide patients with a predictive score that will enable a highly accurate prediction of whether a patient aged 55 and older will or will not convert from Mild Cognitive Impairment to Alzheimer’s disease.
Our web-based platform allows clinical stakeholders to manage and monitor populations. Subject data from Altoida’s tests and other health data, such as prescriptions, traditional biomarker data, and existing conditions, will be available in the platform and can be observed longitudinally to reveal trends and patterns.
When paired with our innovative artificial intelligence, this method will pioneer fully digital predictive neurological disease diagnosis. After our recent Breakthrough Device designation by the FDA, Altoida’s device will provide patients with a predictive score that will enable a highly accurate prediction of whether a patient aged 55 and older will or will not convert from Mild Cognitive Impairment to Alzheimer’s disease.
What Makes Us Different?
At Altoida, we are dedicated to providing a reliable, accessible, and affordable solution for neurological disease clinical trials. Here is what sets us apart from traditional and digitized longitudinal cognitive assessment tools:
| Clinical Trial Needs | What Traditional Tests Offer | What Our Competition Offers | What Altoida Offers |
|---|---|---|---|
| Screen and select subjects for a clinical trial based on the presence of pathology | Up to 64% accuracy for Alzheimer’s diagnosis High-level assessment | Up to 64% accuracy for Alzheimer’s diagnosis High-level assessment | 94% accuracy for Alzheimer’s diagnosis Precise patient placement at a phase on the disease continuum |
| Monitor patients to assess drug efficacy and reach a go/no-go decision | Noisy data Only test cognition | Noisy data Only test cognition | Sensitive, granular data on cognition and function from a test that uses augmented reality |
| Run and manage decentralized trials | Paper/pencil tests | Digital tests | Digital test platform with a connected ecosystem for communication with patients and full study management |
Altoida: Improving and Accelerating Neurological Disease Drug Development
Altoida is powering the next generation of clinical trials. Our app-based medical device will provide pharmaceutical companies with the ability to increase the cost-efficiency, speed, and success of neurological disease clinical trials, from subject screening and monitoring to data analysis. Our Precision Neurology platform and app-based medical device provide:
Cost-effective subject screening: Altoida will enable reliable precision diagnosis for subject screening and selection, conserving the use of expensive imaging. Our device can be used as an initial tool to narrow down the subject pool, filtering out ineligible subjects, before completing imaging or diagnostic procedures necessary for key inclusion criteria.
A robust proxy for traditional endpoints: Altoida will serve as a robust proxy to traditional endpoints in neurological disease clinical trials, providing highly sensitive, generalizable longitudinal data.
Infrastructure for decentralized clinical trials: Altoida’s robust digital test platform, equipped with a connected ecosystem for communication with patients and full study management, provides all necessary components for seamless virtual testing and monitoring as well as statistical data analysis.
To learn more about how Altoida’s Precision Neurology platform and medical device can be used for neurological disease clinical trial subject selection and to remove the longitudinal cognitive assessment and monitoring of subjects, contact us today.