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Patterns of clinically detectable treatment effects with galantamine: a qualitative analysis

Patterns of clinically detectable treatment effects with galantamine: a qualitative analysis
Patterns of clinically detectable treatment effects with galantamine: a qualitative analysis
The Clinician's Interview Based Impression of Change, plus carer interview (CIBIC-Plus) is widely used in anti-dementia drug trials. It includes clinicians' notes about patients' behaviour, function, and cognition, and a 7-point clinical global impression of change scale that summarizes patients' changes during treatment. We analyzed the narrative content of clinicians' notes from a randomized, controlled trial of galantamine, an anti-Alzheimer's disease drug, and identified varying degrees of improvement and decline. In general, while most patients were rated as showing 'no change', considerable changes were seen in such patients, but were judged by clinicians to have been offset by decline in other areas. Most patients rated as 'improved' showed combinations of cognitive, functional and/or behavioural improvement or stability. While patients with signs of cognitive improvement could be found across the scale from 'very much improved' to 'minimally worse', patients with functional improvement were rated as having improved or not having changed. Cognitive declines in several domains or any cognitive decline seen with functional declines were the chief drivers of worsening ratings. The CIBIC-Plus notes have potential value in identifying reproducible patterns of clinically relevant treatment effects provided that data are consistent and specific, and that seemingly contradictory information is carefully explored. Clinicians appear to be skeptical of cognitive changes not supported by like changes in function or behaviour.
alzheimer's disease, cibic-plus, clinical meaningfulness, clinical trials, galantamine
1420-8008
26-33
Joffres, Christine
e97ce212-f383-4212-8383-2fd03a1f83a1
Bucks, Romola S.
95c31da3-2a01-45e7-a648-76d84a49edc4
Haworth, Judy
4fa9f781-38ca-476b-bc4a-5c71e622eb99
Wilcock, Gordon K.
caae0bad-4a40-4ef5-9c19-ea4cb741a0e0
Rockwood, Kenneth
10f3bce2-0bdd-4044-bb43-353b208f65b2
Joffres, Christine
e97ce212-f383-4212-8383-2fd03a1f83a1
Bucks, Romola S.
95c31da3-2a01-45e7-a648-76d84a49edc4
Haworth, Judy
4fa9f781-38ca-476b-bc4a-5c71e622eb99
Wilcock, Gordon K.
caae0bad-4a40-4ef5-9c19-ea4cb741a0e0
Rockwood, Kenneth
10f3bce2-0bdd-4044-bb43-353b208f65b2

Joffres, Christine, Bucks, Romola S., Haworth, Judy, Wilcock, Gordon K. and Rockwood, Kenneth (2003) Patterns of clinically detectable treatment effects with galantamine: a qualitative analysis. Dementia and Geriatric Cognitive Disorders, 15 (1), 26-33. (doi:10.1159/000066673).

Record type: Article

Abstract

The Clinician's Interview Based Impression of Change, plus carer interview (CIBIC-Plus) is widely used in anti-dementia drug trials. It includes clinicians' notes about patients' behaviour, function, and cognition, and a 7-point clinical global impression of change scale that summarizes patients' changes during treatment. We analyzed the narrative content of clinicians' notes from a randomized, controlled trial of galantamine, an anti-Alzheimer's disease drug, and identified varying degrees of improvement and decline. In general, while most patients were rated as showing 'no change', considerable changes were seen in such patients, but were judged by clinicians to have been offset by decline in other areas. Most patients rated as 'improved' showed combinations of cognitive, functional and/or behavioural improvement or stability. While patients with signs of cognitive improvement could be found across the scale from 'very much improved' to 'minimally worse', patients with functional improvement were rated as having improved or not having changed. Cognitive declines in several domains or any cognitive decline seen with functional declines were the chief drivers of worsening ratings. The CIBIC-Plus notes have potential value in identifying reproducible patterns of clinically relevant treatment effects provided that data are consistent and specific, and that seemingly contradictory information is carefully explored. Clinicians appear to be skeptical of cognitive changes not supported by like changes in function or behaviour.

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More information

Published date: 2003
Keywords: alzheimer's disease, cibic-plus, clinical meaningfulness, clinical trials, galantamine

Identifiers

Local EPrints ID: 18561
URI: http://eprints.soton.ac.uk/id/eprint/18561
ISSN: 1420-8008
PURE UUID: 283d9606-73b0-4a49-a1ad-8320594ccb26

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Date deposited: 05 Dec 2005
Last modified: 15 Mar 2024 06:06

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Contributors

Author: Christine Joffres
Author: Romola S. Bucks
Author: Judy Haworth
Author: Gordon K. Wilcock
Author: Kenneth Rockwood

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