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Cognition comes of age: comments on the new FDA draft guidance for early Alzheimer's disease

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Cognition comes of age : comments on the new FDA draft guidance for early Alzheimer's disease. / Harrison, John E.

In: Alzheimer's research & therapy, Vol. 10, No. 1, 29.06.2018, p. 61.

Research output: Contribution to journalArticlepeer-review

Harvard

Harrison, JE 2018, 'Cognition comes of age: comments on the new FDA draft guidance for early Alzheimer's disease', Alzheimer's research & therapy, vol. 10, no. 1, pp. 61. https://doi.org/10.1186/s13195-018-0386-7, https://doi.org/10.1186/s13195-018-0386-7

APA

Harrison, J. E. (2018). Cognition comes of age: comments on the new FDA draft guidance for early Alzheimer's disease. Alzheimer's research & therapy, 10(1), 61. https://doi.org/10.1186/s13195-018-0386-7, https://doi.org/10.1186/s13195-018-0386-7

Vancouver

Harrison JE. Cognition comes of age: comments on the new FDA draft guidance for early Alzheimer's disease. Alzheimer's research & therapy. 2018 Jun 29;10(1):61. https://doi.org/10.1186/s13195-018-0386-7, https://doi.org/10.1186/s13195-018-0386-7

Author

Harrison, John E. / Cognition comes of age : comments on the new FDA draft guidance for early Alzheimer's disease. In: Alzheimer's research & therapy. 2018 ; Vol. 10, No. 1. pp. 61.

Bibtex Download

@article{cc45d600067a4213bf4fbe3941581bf8,
title = "Cognition comes of age: comments on the new FDA draft guidance for early Alzheimer's disease",
abstract = "BACKGROUND: The FDA have recently published draft guidance for the development of treatments for early Alzheimer's disease. Key features of this guidance are the advocacy of sensitive cognitive measures and a taxonomy of disease severity. Whilst desirable patterns of cognitive-functional improvement are included, specific measures, and the magnitude of required effects, are not described.MAIN SECTION: We describe key elements of the guidance content, especially with regard targeting key cognitive domains and the means by which they might be efficiently indexed in the disease stages included in the guidance. We discuss also the opportunities to assess cognitive performance in 'Stage 2' and 'Stage 3' patients, as well as the possibilities for effectively assessing function in the latter category. In this section we review candidate cognitive assessments that we judge are capable of delivering on the guidance specification for sensitive neuropsychological measures. This includes detailed consideration of the ADCS-PACC and Catch-Cog initiatives. With respect to the magnitude of effects, we propose that standardised effect sizes of 0.3 represent a reasonable level of efficacy based on the observation that already marketed drugs on average deliver this level of improvement.CONCLUSIONS: We propose the use of cognitive measures in stage 2 patients to index the cognitive skills known to be compromised early in the Alzheimer's disease process. We recommend extending the traditional interest in episodic memory to include sensitive, reliable and valid measures of attention, working memory and aspects of executive function. We propose a focus on these additional cognitive abilities based on evidence that performance on tests of these domains is moderately well related to functional skills.",
author = "Harrison, {John E}",
year = "2018",
month = jun,
day = "29",
doi = "10.1186/s13195-018-0386-7",
language = "English",
volume = "10",
pages = "61",
journal = "Alzheimer's research & therapy",
issn = "1758-9193",
publisher = "BioMed Central",
number = "1",

}

RIS (suitable for import to EndNote) Download

TY - JOUR

T1 - Cognition comes of age

T2 - comments on the new FDA draft guidance for early Alzheimer's disease

AU - Harrison, John E

PY - 2018/6/29

Y1 - 2018/6/29

N2 - BACKGROUND: The FDA have recently published draft guidance for the development of treatments for early Alzheimer's disease. Key features of this guidance are the advocacy of sensitive cognitive measures and a taxonomy of disease severity. Whilst desirable patterns of cognitive-functional improvement are included, specific measures, and the magnitude of required effects, are not described.MAIN SECTION: We describe key elements of the guidance content, especially with regard targeting key cognitive domains and the means by which they might be efficiently indexed in the disease stages included in the guidance. We discuss also the opportunities to assess cognitive performance in 'Stage 2' and 'Stage 3' patients, as well as the possibilities for effectively assessing function in the latter category. In this section we review candidate cognitive assessments that we judge are capable of delivering on the guidance specification for sensitive neuropsychological measures. This includes detailed consideration of the ADCS-PACC and Catch-Cog initiatives. With respect to the magnitude of effects, we propose that standardised effect sizes of 0.3 represent a reasonable level of efficacy based on the observation that already marketed drugs on average deliver this level of improvement.CONCLUSIONS: We propose the use of cognitive measures in stage 2 patients to index the cognitive skills known to be compromised early in the Alzheimer's disease process. We recommend extending the traditional interest in episodic memory to include sensitive, reliable and valid measures of attention, working memory and aspects of executive function. We propose a focus on these additional cognitive abilities based on evidence that performance on tests of these domains is moderately well related to functional skills.

AB - BACKGROUND: The FDA have recently published draft guidance for the development of treatments for early Alzheimer's disease. Key features of this guidance are the advocacy of sensitive cognitive measures and a taxonomy of disease severity. Whilst desirable patterns of cognitive-functional improvement are included, specific measures, and the magnitude of required effects, are not described.MAIN SECTION: We describe key elements of the guidance content, especially with regard targeting key cognitive domains and the means by which they might be efficiently indexed in the disease stages included in the guidance. We discuss also the opportunities to assess cognitive performance in 'Stage 2' and 'Stage 3' patients, as well as the possibilities for effectively assessing function in the latter category. In this section we review candidate cognitive assessments that we judge are capable of delivering on the guidance specification for sensitive neuropsychological measures. This includes detailed consideration of the ADCS-PACC and Catch-Cog initiatives. With respect to the magnitude of effects, we propose that standardised effect sizes of 0.3 represent a reasonable level of efficacy based on the observation that already marketed drugs on average deliver this level of improvement.CONCLUSIONS: We propose the use of cognitive measures in stage 2 patients to index the cognitive skills known to be compromised early in the Alzheimer's disease process. We recommend extending the traditional interest in episodic memory to include sensitive, reliable and valid measures of attention, working memory and aspects of executive function. We propose a focus on these additional cognitive abilities based on evidence that performance on tests of these domains is moderately well related to functional skills.

U2 - 10.1186/s13195-018-0386-7

DO - 10.1186/s13195-018-0386-7

M3 - Article

C2 - 29958538

VL - 10

SP - 61

JO - Alzheimer's research & therapy

JF - Alzheimer's research & therapy

SN - 1758-9193

IS - 1

ER -

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