Use of nonintrusive sensor-based information and communication technology for real-world evidence for clinical trials in dementia

Stefan Teipel, Alexandra König, Jesse Hoey, Jeffrey Kaye, Frank Krüger, Julie M. Robillard, Thomas Kirste, Claudio Babiloni

Research output: Contribution to journalShort survey

4 Citations (Scopus)

Abstract

Cognitive function is an important end point of treatments in dementia clinical trials. Measuring cognitive function by standardized tests, however, is biased toward highly constrained environments (such as hospitals) in selected samples. Patient-powered real-world evidence using information and communication technology devices, including environmental and wearable sensors, may help to overcome these limitations. This position paper describes current and novel information and communication technology devices and algorithms to monitor behavior and function in people with prodromal and manifest stages of dementia continuously, and discusses clinical, technological, ethical, regulatory, and user-centered requirements for collecting real-world evidence in future randomized controlled trials. Challenges of data safety, quality, and privacy and regulatory requirements need to be addressed by future smart sensor technologies. When these requirements are satisfied, these technologies will provide access to truly user relevant outcomes and broader cohorts of participants than currently sampled in clinical trials.

Original languageEnglish (US)
Pages (from-to)1216-1231
Number of pages16
JournalAlzheimer's and Dementia
Volume14
Issue number9
DOIs
StatePublished - Sep 1 2018

Fingerprint

Pragmatic Clinical Trials
Dementia
Communication
Technology
Cognition
Clinical Trials
Prodromal Symptoms
Equipment and Supplies
Privacy
Randomized Controlled Trials
Safety

ASJC Scopus subject areas

  • Epidemiology
  • Health Policy
  • Developmental Neuroscience
  • Clinical Neurology
  • Geriatrics and Gerontology
  • Cellular and Molecular Neuroscience
  • Psychiatry and Mental health

Cite this

Use of nonintrusive sensor-based information and communication technology for real-world evidence for clinical trials in dementia. / Teipel, Stefan; König, Alexandra; Hoey, Jesse; Kaye, Jeffrey; Krüger, Frank; Robillard, Julie M.; Kirste, Thomas; Babiloni, Claudio.

In: Alzheimer's and Dementia, Vol. 14, No. 9, 01.09.2018, p. 1216-1231.

Research output: Contribution to journalShort survey

Teipel, Stefan ; König, Alexandra ; Hoey, Jesse ; Kaye, Jeffrey ; Krüger, Frank ; Robillard, Julie M. ; Kirste, Thomas ; Babiloni, Claudio. / Use of nonintrusive sensor-based information and communication technology for real-world evidence for clinical trials in dementia. In: Alzheimer's and Dementia. 2018 ; Vol. 14, No. 9. pp. 1216-1231.
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