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BackgroundThe global burden of Alzheimer's disease and related dementias is rapidly increasing, particularly in low- and middle-income countries where access to specialized healthcare is limited. Neuropsychological tests are essential diagnostic tools, but their administration requires trained professionals, creating screening barriers. Automated computational assessment presents a cost-effective solution for global dementia screening. ObjectiveTo develop and validate an artificial intelligence-based screening tool using the Trail Making Test (TMT), demographic information, completion times, and drawing analysis for enhanced dementia detection. MethodsWe developed: (1) non-image models using demographics and TMT completion times, (2) image-only models, and (3) fusion models. Models were trained and validated on data from the Framingham Heart Study (FHS) (N = 1252), the Long Life Family Study (LLFS) (N = 1613), and the combined cohort (N = 2865). ResultsOur models, integrating TMT drawings, demographics, and completion times, excelled in distinguishing dementia from normal cognition. In the LLFS cohort, we achieved an Area Under the Receiver Operating Characteristic Curve (AUC) of 98.62%, with sensitivity/specificity of 87.69%/98.26%. In the FHS cohort, we obtained an AUC of 96.51%, with sensitivity/specificity of 85.00%/96.75%. ConclusionsOur method demonstrated superior performance compared to traditional approaches using age and TMT completion time. Adding images captures subtler nuances from the TMT drawing that traditional methods miss. Integrating the TMT drawing into cognitive assessments enables effective dementia screening. Future studies could aim to expand data collection to include more diverse cohorts, particularly from less-resourced regions. 

Digital voice recordings can offer affordable, accessible ways to evaluate behavior and function. We assessed how combining different low-level voice descriptors can evaluate cognitive status. Using voice recordings from neuropsychological exams at the Framingham Heart Study, we developed a machine learning framework fusing spectral, prosodic, and sound quality measures early in the training cycle. The model’s area under the receiver operating characteristic curve was 0.832 (±0.034) in differentiating persons with dementia from those who had normal cognition. This offers a data-driven framework for analyzing minimally processed voice recordings for cognitive assessment, highlighting the value of digital technologies in disease detection and intervention. 

“Digital biomarker” is a term broadly and indiscriminately applied and often limited in its conceptualization to mimic well-established biomarkers as defined and approved by regulatory agencies such as the United States Food and Drug Administration (FDA). There is a practical urgency to revisit the definition of a digital biomarker and expand it beyond current methods of identification and validation. Restricting the promise of digital technologies within the realm of currently defined biomarkers creates a missed opportunity. A whole new field of prognostic and early diagnostic digital biomarkers driven by data science and artificial intelligence can break the current cycle of high healthcare costs and low health quality that is being driven by today's chronic disease detection and treatment approaches. This new class of digital biomarkers will be dynamic and require developing new FDA approval pathways and next-generation gold standards. 

Abstract Background Identification of reliable, affordable, and easy-to-use strategies for detection of dementia is sorely needed. Digital technologies, such as individual voice recordings, offer an attractive modality to assess cognition but methods that could automatically analyze such data are not readily available. Methods and findings We used 1264 voice recordings of neuropsychological examinations administered to participants from the Framingham Heart Study (FHS), a community-based longitudinal observational study. The recordings were 73 min in duration, on average, and contained at least two speakers (participant and examiner). Of the total voice recordings, 483 were of participants with normal cognition (NC), 451 recordings were of participants with mild cognitive impairment (MCI), and 330 were of participants with dementia (DE). We developed two deep learning models (a two-level long short-term memory (LSTM) network and a convolutional neural network (CNN)), which used the audio recordings to classify if the recording included a participant with only NC or only DE and to differentiate between recordings corresponding to those that had DE from those who did not have DE (i.e., NDE (NC+MCI)). Based on 5-fold cross-validation, the LSTM model achieved a mean (±std) area under the receiver operating characteristic curve (AUC) of 0.740 ± 0.017, mean balanced accuracy of 0.647 ± 0.027, and mean weighted F1 score of 0.596 ± 0.047 in classifying cases with DE from those with NC. The CNN model achieved a mean AUC of 0.805 ± 0.027, mean balanced accuracy of 0.743 ± 0.015, and mean weighted F1 score of 0.742 ± 0.033 in classifying cases with DE from those with NC. For the task related to the classification of participants with DE from NDE, the LSTM model achieved a mean AUC of 0.734 ± 0.014, mean balanced accuracy of 0.675 ± 0.013, and mean weighted F1 score of 0.671 ± 0.015. The CNN model achieved a mean AUC of 0.746 ± 0.021, mean balanced accuracy of 0.652 ± 0.020, and mean weighted F1 score of 0.635 ± 0.031 in classifying cases with DE from those who were NDE. Conclusion This proof-of-concept study demonstrates that automated deep learning-driven processing of audio recordings of neuropsychological testing performed on individuals recruited within a community cohort setting can facilitate dementia screening. 

Background: Widespread dementia detection could increase clinical trial candidates and enable appropriate interventions. Since the Clock Drawing Test (CDT) can be potentially used for diagnosing dementia-related disorders, it can be leveraged to develop a computer-aided screening tool. Objective: To evaluate if a machine learning model that uses images from the CDT can predict mild cognitive impairment or dementia. Methods: Images of an analog clock drawn by 3,263 cognitively intact and 160 impaired subjects were collected during in-person dementia evaluations by the Framingham Heart Study. We processed the CDT images, participant’s age, and education level using a deep learning algorithm to predict dementia status. Results: When only the CDT images were used, the deep learning model predicted dementia status with an area under the receiver operating characteristic curve (AUC) of 81.3% ± 4.3%. A composite logistic regression model using age, level of education, and the predictions from the CDT-only model, yielded an average AUC and average F1 score of 91.9% ±1.1% and 94.6% ±0.4%, respectively. Conclusion: Our modeling framework establishes a proof-of-principle that deep learning can be applied on images derived from the CDT to predict dementia status. When fully validated, this approach can offer a cost-effective and easily deployable mechanism for detecting cognitive impairment.