Finding MCI and early Alzheimer's participants: cognitive pre-screening for clinical trials
Why Alzheimer's and MCI trials struggle to recruit, where screen failures come from, and how structured cognitive pre-screening and digital biomarkers can help sponsors and sites.
Quick answer
Alzheimer's drug development has 138 drugs in 182 trials, yet most eligible people never join one, and many who are referred fail screening. Structured, multilingual cognitive pre-screening before costly biomarker tests can widen the funnel, reach new populations such as India, and reduce screen failures.
Why is Alzheimer's trial recruitment so hard?
Trials need people at the MCI or early stage, but most are never assessed, referral pathways are thin, and many who are referred fail on cognitive or biomarker criteria. About 99 in 100 eligible people never join a trial.
Where the funnel leaks
- People with early changes are not assessed at all.
- Assessment tools are not adapted to language and schooling, so many people are excluded.
- Expensive amyloid PET or CSF tests are done on people who do not meet cognitive criteria.
- Trial populations are mostly from North America and Europe.
What structured pre-screening adds
- Version-locked tasks with an audit trail, so every site runs the same assessment.
- Results by area of thinking that map to inclusion criteria.
- Multilingual delivery, reaching populations underrepresented in trials.
- A cheaper first step before blood-based or imaging biomarkers.
Digital biomarkers: voice and eye
Research shows that language changes can appear years before an Alzheimer's diagnosis. Speech features (pauses, pitch, word choice) and eye movements (saccades, reaction time) are being studied as digital biomarkers. Zero Dementia's voice and eye engine is in development and will be validated before any use in decisions.
Frequently asked questions
A first check, before formal screening, to see whether someone is likely to meet the trial's criteria, which saves cost and time for participants and sites.
Measurable signals collected by devices, such as speech patterns, eye movements, typing or gait, studied as early indicators of cognitive change.
Zero Dementia is built for multilingual use and is open to research and pilot partnerships in other countries, subject to local approvals.
Find MCI participants earlier
A structured, version-locked assessment to support pre-screening for MCI and early Alzheimer's studies.
Talk to us about your studySources
- 1.Alzheimer's disease drug development pipeline: 2025. Alzheimer's & Dementia: TRCI (Cummings et al.), 2025.
- 2.Linguistic markers predict onset of Alzheimer's disease. EClinicalMedicine (Eyigoz et al.), 2020.
- 3.World Alzheimer Report 2021: Journey through the diagnosis of dementia. Alzheimer's Disease International, 2021.
This article is for information and does not replace advice from a doctor. If you notice changes in memory or thinking, see a doctor.
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