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Validation status of cognitive digital assessments by the FDA BEST framework and context of use in preclinical AD studies: A systematic review
Porta-Mas C, Grau-Rivera O, Gispert JD, Blasco GS, Sánchez-Benavides G.. Alzheimer's & dementia : the journal of the Alzheimer's Association, 2025-12-01
Topic: Risk, prevention and care in population studies
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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APA 7th
Porta-Mas, C., Grau-Rivera, O., Gispert, J. D., Blasco, G. S., & Sánchez-Benavides, G. (2025). 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. https://doi.org/10.1002/alz.70753
Vancouver
Porta-Mas C, Grau-Rivera O, Gispert JD, Blasco GS, Sánchez-Benavides G. 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. 2025. doi:10.1002/alz.70753. PMID: 41368997.
BibTeX
@article{portamas2025-41368997,
author = {Porta-Mas, C. and Grau-Rivera, O. and Gispert, J. D. and Blasco, G. S. and Sánchez-Benavides, G.},
title = {{Validation status of cognitive digital assessments by the FDA BEST framework and context of use in preclinical AD studies: A systematic review}},
journal = {Alzheimer's \& dementia : the journal of the Alzheimer's Association},
year = {2025},
doi = {10.1002/alz.70753},
pmid = {41368997},
url = {https://doi.org/10.1002/alz.70753}
}
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Key findings
- Our findings suggest potential use as risk or monitoring biomarkers, though further longitudinal validation is needed.
- 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.
Study details
- Study designsystematic review
- Evidence strengthHigh
How this study scored 76/100
Published in a leading specialty journal, and it is a systematic review of all the studies on the question. Scored zero for sample size, effect reported and studied in people because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record and multi-centre collaboration, so those were left out: it earned 44 of the 58 points we could judge it on, which is 76 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Alzheimer's & dementia : the journal of the Alzheimer's Association) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 12 / 12 | A systematic review of all the studies on the question |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 4 / 5 | 2025 — within 3 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| Randomised / blinded | 0 / 2 | A review of other studies — randomisation is not credited here |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 41368997) |
| Free to read | 2 / 2 | Free to read |
| Points | 44 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 44 of the 58 points we could judge it on is 76 out of 100. |
| Total | 76 / 100 | — |
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