4.5 Article

Pilot Evaluation of the Unsupervised, At-Home Cogstate Brief Battery in ADNI-2

Journal

JOURNAL OF ALZHEIMERS DISEASE
Volume 83, Issue 2, Pages 915-925

Publisher

IOS PRESS
DOI: 10.3233/JAD-210201

Keywords

Alzheimer's disease; clinical trials as a topic; cognition; digital technology; healthcare research

Categories

Funding

  1. Alzheimer's Disease Neuroimaging Initiative (ADNI) (National Institutes of Health) [U01AG024904]
  2. DODADNI (Department of Defense) [W81XWH-12-2-0012]
  3. National Institute on Aging
  4. National Institute of Biomedical Imaging and Bioengineering
  5. AbbVie
  6. Alzheimer's Association
  7. Alzheimer's Drug Discovery Foundation
  8. Araclon Biotech
  9. BioClinica, Inc.
  10. Biogen
  11. Bristol-Myers Squibb Company
  12. CereSpir, Inc.
  13. Cogstate
  14. Eisai Inc.
  15. Elan Pharmaceuticals, Inc.
  16. Eli Lilly and Company
  17. EuroImmun
  18. F. Hoffmann-La Roche Ltd
  19. Genentech, Inc.
  20. Fujirebio
  21. GE Healthcare
  22. IXICO Ltd
  23. Janssen Alzheimer Immunotherapy Research & Development, LLC
  24. Johnson & Johnson Pharmaceutical Research & Development LLC
  25. Lumosity
  26. Lundbeck
  27. Merck Co., Inc.
  28. Meso Scale Diagnostics, LLC
  29. NeuroRx Research
  30. Neurotrack Technologies
  31. Novartis Pharmaceuticals Corporation
  32. Pfizer Inc.
  33. Piramal Imaging
  34. Servier
  35. Takeda Pharmaceutical Company
  36. Transition Therapeutics
  37. The Canadian Institutes of Health Research

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The study evaluated the feasibility of at-home, self-completion of the CBB in the ADNI over 24 months, showing potential for use in MCI groups. However, data collection declined over time, suggesting the need for strategies to maintain compliance.
Background: There is a need for feasible, scalable assessments to detect cognitive impairment and decline. The Cogstate Brief Battery (CBB) is validated for Alzheimer's disease (AD) and in unsupervised and bring your own device contexts. The CBB has shown usability for self-completion in the home but has not been employed in this way in a multisite clinical trial in AD. Objective: The objective of the pilot was to evaluate feasibility of at-home, self-completion of the CBB in the Alzheimer's Disease Neuroimaging Initiative (ADNI) over 24 months. Methods: The CBB was included as a pilot for cognitively normal (CN) and mild cognitive impairment (MCI) participants in ADNI-2, invited to take the assessment in-clinic, then at at-home over a period of 24 months follow-up. Data were analyzed to explore acceptability/usability, concordance of in-clinic and at-home assessment, and validity. Results: Data were collected for 104 participants (46 CN, 51 MCI, and 7 AD) who consented to provide CBB data. Subsequent analyses were performed for the CN and MCI groups only. Test completion rates were 100% for both the first in-clinic supervised and first at-home unsupervised assessments, with few repeat performances required. However, available follow-up data declined sharply over time. Good concordance was seen between in-clinic and at-home assessments, with non-significant and small effect size differences (Cohen's d between -0.04 and 0.28) and generally moderate correlations (r = 0.42 to 0.73). Known groups validity was also supported (11/16 comparisons with Cohen's d >= 0.3). Conclusion: These data demonstrate the feasibility of use for the CBB for unsupervised at-home, testing, including MCI groups. Optimal approaches to the application of assessments to support compliance over time remain to be determined.

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