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Can Dementia Trials Be Decentralized Without Losing Data Quality?

Signant Health
Jun 18, 2026
Video
Participant dropout strategies in anti-obesity medication clinical trials

Decentralizing dementia trials requires clinical expertise, scale-specific training, and copyright holder approval before remote administration begins.  

In this conversation, Dr. David Miller, Clinical Vice President at Signant Health and Chair of the Alzheimer's Association Research Roundtable, discusses how a 1,800-participant, 12-country dementia study was successfully migrated from site-based to remote assessment during COVID-19, with endpoint reliability data confirming remote assessment quality on par with in-person ratings. 

Key Points 

  • Remote administration of complex clinician-reported outcome measures in dementia trials requires dedicated training curricula for remote raters covering hygiene differences between in-person and remote scale administration.
  • Mobile infusion nurses can serve as on-site proxies for scale elements that require physical presence, such as reorienting materials during cognitive assessments, enabling remote readers to complete assessments without missing data.
  • Endpoint reliability analysis combining audio recordings with entered data confirmed that remote assessment quality in this 1,800-participant dementia study was on par with in-person administration.
  • Copyright holder approval is a prerequisite for remote scale administration. Signant's in-house scientists, including co-authors of assessment scoring manuals, are positioned to engage copyright holders peer-to-peer on methodology.
  • Cognitive decline over the course of long-duration dementia studies (typically 18 months+) may progressively impair participants' ability to navigate remote technology, a factor that hybrid trial design must account for from the protocol stage.
  • The full video features David Miller's framework for evaluating which scale elements can be administered remotely, which require in-person presence, and how to structure a hybrid model that protects data integrity throughout. 
 
Why It Matters Now: Dementia Trial Design Cannot Afford Avoidable Data Loss 
 
For a participant in a long-duration dementia trial, a missed visit is rarely recoverable because cognitive decline progresses, or caregiver circumstances change. The window in which a participant can reliably contribute assessable data is finite, and every lost visit represents irreplaceable evidence. When COVID-19 forced site closures in spring 2020, sponsors faced a direct choice between losing enrolled participant data and continuing remotely. 
 
The challenge was acute in dementia. Complex clinician-reported outcome measures, many requiring physical materials, physical proximity, and audio recording for subsequent endpoint reliability review, were not designed for remote administration. Scale copyright holders had not validated remote use. Raters had no training framework for conducting assessments without sitting across from the participant. 
 
The FDA's 2023 draft guidance on decentralized clinical trials signals a direction of travel that sponsors in neurology and psychiatry are already responding to. For dementia programs entering design today, the question is how to structure it so that data quality holds across the full study duration. 
 
What the Video Covers: A Framework Built Under Pressure, Validated by Data 
 
Sponsors considering remote or hybrid assessment in dementia studies have faced a legitimate barrier: there was no published framework for doing it in complex cognitive scales, and no endpoint reliability data to support the approach. The pandemic removed the option of waiting. 
 
What Signant's scientific team built under those conditions is directly applicable to trials designed today. The training model developed for this study separated responsibilities by role: remote raters received curriculum-based training on scale administration hygiene for video-based assessment, site raters were deputized to train mobile infusion nurses on the physical elements they would assist with, and all parties were trained to avoid behaviors that could exacerbate placebo response. The endpoint reliability program, combining audio recording review with entered data, provided the quality verification the sponsor needed. 
 
David Miller covers the specific logistical and clinical barriers that remain for studies where no mobile infusion nurse is present, including internet connectivity, screen size consistency, participant technology literacy, cognitive decline over study duration, and the handling of physical source documents such as drawings. For sponsors and CROs evaluating hybrid versus fully decentralized models for upcoming dementia programs, this conversation provides clinical reasoning and operational detail to inform that decision. The full video contains the complete framework discussion. 
 

"We were able to show that the quality of the assessments done remotely was on par with the in-person quality. So, we were quite confident that in addition to being able to do these scales remotely, we were confident in the quality of the administration and scoring." - David Miller, MD, MA, Clinical Vice President, Signant Health; Chair, Alzheimer's Association Research Roundtable  

Can complex cognitive assessments like the ADAS-Cog be administered remotely in dementia trials?

Yes, with specific conditions met. Copyright holder approval is required, as remote administration was not part of the original scale design. Raters need dedicated training on remote assessment hygiene. Physical elements requiring in-person assistance, such as reorienting materials, can be delegated to an on-site proxy. Endpoint reliability analysis in an 1,800-participant study confirmed remote quality on par with in-person administration.

What are the main risks of remote assessment in long-duration dementia studies?

The primary risks include internet connectivity gaps, inconsistent screen sizes across participant homes, participant and caregiver technology literacy, progressive cognitive decline reducing participants' ability to navigate remote systems over an 18-month or longer study, and the need to return physical source documents, such as drawings, to the site. Each requires protocol-level planning before the study starts.

How should sponsors decide between hybrid and fully decentralized models for dementia trials?

The decision should be driven by which scale elements require physical presence and cannot be delegated to an on-site proxy, the availability of a mobile nurse or equivalent for in-home visits, the expected duration of the study relative to anticipated cognitive decline in the participant population, and whether key visits at defined timepoints require in-clinic attendance for clinical or regulatory reasons.

 
 

AUTHOR BIO 

Name: David Miller 
Title and Credentials: MD, MA, Clinical Vice President, Signant Health 
Bio: David Miller, MD, MA, is Clinical Vice President at Signant Health and a geriatric psychiatrist with over 25 years of experience in patient care, clinical research, and teaching. He has served as a principal investigator in dementia studies and currently chairs the Alzheimer's Association Research Roundtable. He is a co-author of the ADAS-Cog administration and scoring manual (2013, 2015).  

This conversation is hosted by Dawie Wessels, MD, Chief Medical Officer at Signant Health, whose clinical and multinational development expertise spans multiple therapeutic areas. 

 

Evaluating remote or hybrid assessment design for an upcoming dementia program? Speak to David Miller, MD, MA, about scale selection, copyright holder engagement, and endpoint reliability strategy for decentralized CNS trials. 

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