SynthesisAlzheimer's & dementia : the journal of the Alzheimer's Association2025
Validation status of cognitive digital assessments by the FDA BEST framework and context of use in preclinical AD studies: A systematic review.
Synthesis in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Validation status of cognitive digital assessments by the FDA BEST framework and context of use in preclinical AD studies: A systematic review.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Pooled it
- Speech-based digital cognitive assessment for clinical trials: Detecting cognitive impairment stages and AD biomarker relations across European cohorts.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Article
- AI-enabled digital phenotyping for Alzheimer's disease: a review of multimodal sensor integration and symptom trajectories.Alzheimer's research & therapy · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
Digital cognitive assessments have rapidly expanded in Alzheimer's disease (AD) research, offering a sensitive, scalable, and cost-effective alternative to traditional neuropsychological tests. This systematic review examines the validation and utility of digital cognitive assessments in cognitively normal (CN) individuals and explores their potential classification within the US Food and Drug Administration's Biomarkers, Endpoints, and other Tools (FDA BEST) framework. Additionally, we provide recommendations to consider for their implementation. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we searched PubMed for studies validating digital cognitive tools against paper-based tests and standard AD biomarkers, including measures of amyloid beta and tau in fluid and neuroimaging biomarkers. Our findings suggest potential use as risk or monitoring biomarkers, though further longitudinal validation is needed. This review highlights the latest advancements in digital cognitive assessments, their role as novel AD biomarkers, and essential considerations for their effective use in AD. HIGHLIGHTS: Digital cognitive assessments for preclinical Alzheimer's disease (AD) are associated with established biomarkers, including paper-based neuropsychological tests and amyloid beta and tau measures in both fluid and neuroimaging techniques. These assessments have the potential to serve as novel AD biomarkers classified within the US Food and Drug Administration's Biomarkers, Endpoints, and other Tools framework and context of use, but long-term studies spanning different disease stages are needed to fully establish their validity for some of the biomarker categories. Several biases may be present when conducting digital cognitive assessments; their optimal use should follow specific recommendations to minimize them.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.