SAARBRÜCKEN, Germany–(BUSINESS WIRE)–New peer-reviewed research published by ki:elements and the PROSPECT-AD consortium demonstrates that the company’s Speech Biomarker for Cognition (SB-C) can reliably detect cognitive impairment and signal underlying Alzheimer’s disease (AD) pathology through an AI voice agent that calls participants at home. The study, involving 736 participants across five independent cohorts in Spain, the UK, Germany, and Sweden, is one of the largest and most geographically diverse validations of a speech-based digital cognitive assessment to date.
The research confirms that the SB-C consistently separates cognitive unimpaired individuals from those with mild cognitive impairment (MCI) or early dementia. Notably, the tool demonstrated a significant ability to classify Alzheimer’s CSF biomarker status remotely. It identified amyloid-beta positivity with an AUC of up to 0.74 and phosphorylated tau 181 positivity with an AUC of up to 0.82.
A Scalable Pre-Screen for Clinical Trials
Recruiting for AD clinical trials is traditionally one of the costliest phases of drug development, often requiring invasive and expensive procedures like lumbar punctures or PET scans to confirm eligibility. The SB-C offers the biopharma industry a validated first-pass enrichment layer, identifying individuals most likely to meet biomarker-positive eligibility criteria before committing to expensive invasive procedures.
- Fully Automated Delivery: The ki:elements Mili platform calls participants, administers the 10-minute assessment through a voice agent, and generates an automatic biomarker score.
- Multilingual Sensitivity: The SB-C proved effective across Spanish, Catalan, German, English, and Swedish language groups, utilizing 70 distinct speech features to index cognitive efficiency.
- Rigorous Validation: The SB-C is validated following the Digital Medicine Society’s V3 Framework and is currently deployed as a pre-screening tool in multiple AD clinical trials. It demonstrates strong convergent validity with clinical “gold standards” such as MMSE and PACC-5. By quantifying subtle functional speech changes, the platform provides a window into cognitive health that complements traditional paper tests.
“We’ve known for years that one of the biggest hurdles in prevention trials is getting the right people into studies efficiently and at scale,” said Prof Craig Ritchie, Professor of Brain health and Neurodegenerative Medicine at University of St Andrews and CEO and Founder of Scottish Brain Sciences, and co-author of the publication. “In this era of early-intervention Alzheimer’s research, a validated digital cognitive assessment that correlates with AD pathology in multiple languages, without a clinician, opens up a generation of prevention trials that weren’t feasible before.”
“This study gives us real-world, multi-site evidence that a speech assessment can track with established cognitive measures and distinguish patients by their underlying pathology,” said Dr. Alexandra König, Chief Clinical Research Officer of ki:elements and corresponding author of the study. “For sponsors, this translates directly into faster, smarter recruitment, and a lower-burden tool for participants.”
About ki:elements
ki:elements is a Germany-based digital health company specializing in AI-driven speech assessments. Its Mili platform and SB-C biomarker are validated, automated tools designed for global-scale deployment. The company partners with leading pharmaceutical companies and research institutions to accelerate early detection and decentralized clinical trial execution in Alzheimer’s disease and other central nervous system conditions.
Contacts
Media Contact
Sandya Iyer
Email: sandya.iyer@ki-elements.de
Website: www.ki-elements.de
