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Review
. 2018 Jan;46 Suppl 1(Suppl 1):S53-S56.
doi: 10.1016/j.parkreldis.2017.07.022. Epub 2017 Jul 26.

Integration of technology-based outcome measures in clinical trials of Parkinson and other neurodegenerative diseases

Carlo Alberto Artusi  1 , Murli Mishra  2 , Patricia Latimer  2 , Joaquin A Vizcarra  2 , Leonardo Lopiano  3 , Walter Maetzler  4 , Aristide Merola  2 , Alberto J Espay  5
Affiliations
Review

Integration of technology-based outcome measures in clinical trials of Parkinson and other neurodegenerative diseases

Carlo Alberto Artusi et al. Parkinsonism Relat Disord. 2018 Jan.

Abstract

Introduction: We sought to review the landscape of past, present, and future use of technology-based outcome measures (TOMs) in clinical trials of neurodegenerative disorders.

Methods: We systematically reviewed PubMed and ClinicalTrials.gov for published and ongoing clinical trials in neurodegenerative disorders employing TOMs. In addition, medical directors of selected pharmaceutical companies were surveyed on their companies' ongoing efforts and future plans to integrate TOMs in clinical trials as primary, secondary, or exploratory endpoints.

Results: We identified 164 published clinical trials indexed in PubMed that used TOMs as outcome measures in Parkinson disease (n = 132) or other neurodegenerative disorders (n = 32). The ClinicalTrials.gov search yielded 42 clinical trials using TOMs, representing 2.7% of ongoing trials. Sensor-based technology accounted for over 75% of TOMs applied. Gait and physical activity were the most common targeted domains. Within the next 5 years, 83% of surveyed pharmaceutical companies engaged in neurodegenerative disorders plan to deploy TOMs in clinical trials.

Conclusion: Although promising, TOMs are underutilized in clinical trials of neurodegenerative disorders. Validating relevant endpoints, standardizing measures and procedures, establishing a single platform for integration of data and algorithms from different devices, and facilitating regulatory approvals should advance TOMs integration into clinical trials.

Keywords: Alzheimer disease; Amyotrophic lateral sclerosis; Neurodegenerative; Parkinson disease; Technology; Technology-based objective measures.

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Figures

Fig. 1.
Fig. 1.. Published clinical trials integrating technology-based outcome measures.
Total number of clinical trials employing technology-based outcome measure: Parkinson disease (n = 132); Alzheimer disease (n = 19); Huntington disease (n = 3); Amyotrophic lateral sclerosis (n = 2); Spinocerebellar ataxia (n = 2), mild cognitive impairment (n = 2), Lewy bodies dementia (n = 1), Friedreich’s ataxia (n = 1), Hereditary spastic paraparesis (n = 1), and Progressive supranuclear palsy (n = 1).
Fig. 2.
Fig. 2.. Ongoing clinical trials integrating technology-based primary, secondary, or exploratory outcome measures.
Data extracted from Clinicaltrials.gov up to June 2017.
Fig. 3.
Fig. 3.
Type of technology-based outcome measure and functional domain assessed.
See this image and copyright information in PMC

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