Document is current

Article History

Accepted: 11 June 2024

First Online: 27 June 2024

Declarations

:

: J.L.C. is supported by National Institute of General Medical Sciences (NIGMS) grant P20GM109025, National Institute on Aging (NIA) grant R35AG71476, NIA R25 AG083721-01, the Alzheimer’s Disease Drug Discovery Foundation (ADDF), the Ted and Maria Quirk Endowment, and the Joy Chambers-Grundy Endowment. Funding from these sources was used to provide Open Access. A.L.-O., J.W.K., D.C., and J.C. declare no funding relevant to this article.

: J.C. has provided consultation to Acadia, Acumen, ALZpath, Aprinoia, Artery, Biogen, Biohaven, BioXcel, Bristol-Myers Squib, Eisai, Fosun, GAP Foundation, Janssen, Karuna, Lighthouse, Lilly, Lundbeck, LSP/eqt, Merck, MoCA Cognition, New Amsterdam, Novo Nordisk, Optoceutics, Otsuka, Oxford Brain Diagnostics, Prothena, ReMYND, Roche, Scottish Brain Sciences, Signant Health, Simcere, sinaptica, TrueBinding, and Vaxxinity pharmaceutical, assessment, and investment companies. J.C. owns the copyright of the Neuropsychiatric Inventory. J.C. has stocks/options in Artery, Vaxxinity, Behrens, Alzheon, MedAvante-Prophase, and Acumen. D.C., J.P., A.L., and J. Chen have no disclosures.

: This is a narrative review, does not involve any patient-level information, and does not require review by an institutional review board.

: No patients were involved in this report and no informed consent was needed. All other participants were voluntarily engaged, and no documentation of their consent is required. All have approved this article.

: No patients were involved in this narrative review. No patient identification could be derived from this review, and no consent to publish is required.

: Our narrative review is based on an extensive review of and knowledge of the relevant literature. All sources of information are documented and are provided in the reference section. Of particular interest is our complete documentation of the regulatory guidance documents from the Food and Drug Administration (FDA), which are key to aspects of this review.

: No statical analyses were conducted, and no availability of code comment is relevant.

: All authors participated in the development of this narrative review. The idea was initiated by J.L.C. with important preliminary contributions from a A.O.-L. and J.W.K. A.L.O., J.W.K., D.C., and J.C. all were drafting authors of individual sections of this review. A.O.-L. and J.W.K. were responsible for the biomarker section. D.C. and J.C. were responsible for the computational strategy section. Each author performed the literature search relevant to their area of manuscript development. All of the authors were involved in revision of the work, all confirm that they have read and approve of the final submitted manuscript, and all agree to be accountable for the work.