The Clinician's Interview-Based Impression of Change (Plus caregiver input) and goal attainment in two dementia drug trials: Clinical meaningfulness and the initial treatment response

Justin Stanley; Susan E. Howlett; Taylor Dunn; Kenneth Rockwood

doi:10.1002/alz.12242

The Clinician's Interview-Based Impression of Change (Plus caregiver input) and goal attainment in two dementia drug trials: Clinical meaningfulness and the initial treatment response

Justin Stanley, Susan E. Howlett, Taylor Dunn, Kenneth Rockwood

Medicine

Research output: Contribution to journal › Article › peer-review

10 Citations (Scopus)

Abstract

INTRODUCTION: The Clinician's Interview-Based Impression of Change Plus caregiver input (CIBIC-Plus) has been widely used in dementia drug trials to evaluate cognition, behavior, and function. New trials of symptomatic drugs forecast renewed interest in this measure. METHODS: To test its clinical meaningfulness, we examined how CIBIC-Plus performed in two cholinesterase inhibitor trials compared to goal attainment scaling Scale (GAS) scores, a patient-reported outcome measure. RESULTS: Net goal attainment was seen for all but one GAS domains in subjects who improved on the CIBIC-Plus. Subjects who improved initially on CIBIC-Plus scores were likely to remain improved across all other outcomes for each trial's duration, except for Disability Assessment for Dementia scores. DISCUSSION: The initial response to treatment, as assessed by CIBIC-Plus, remained stable for most outcome measures. Even small CIBIC-Plus improvement changes are associated with clinically meaningful change as assessed by GAS. Other tests detect decline better than improvement.

Original language	English
Pages (from-to)	856-865
Number of pages	10
Journal	Alzheimer's and Dementia
Volume	17
Issue number	5
DOIs	https://doi.org/10.1002/alz.12242
Publication status	Published - May 2021

Bibliographical note

Funding Information:
ACADIE (1998-1999) was an investigator initiated, open-label clinical trial sponsored by Pfizer Canada. VISTA (2001-2005) was a registered (ISRCTN26167328) peer-reviewed, investigator-initiated, RCT co-funded by Janssen-Ortho Inc. and the Canadian Institutes of Health Research, through a CIHR Rx & D operating grant (DCT-49981). Kenneth Rockwood is supported by the Dalhousie Medical Research Foundation as the Kathryn Allen Weldon Professor of Alzheimer Research. DGI Clinical Inc. is supported by the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP), the Atlantic Canada Opportunities Agency (ACOA) and Innovacorp. ACADIE was solely sponsored by Pfizer Canada, and VISTA was co-funded by Janssen-Ortho Inc and Canadian Institutes of Health Research, through CIHR Rx & D (DCT-49981).

Funding Information:
ACADIE (1998‐1999) was an investigator initiated, open‐label clinical trial sponsored by Pfizer Canada. VISTA (2001‐2005) was a registered (ISRCTN26167328) peer‐reviewed, investigator‐initiated, RCT co‐funded by Janssen‐Ortho Inc. and the Canadian Institutes of Health Research, through a CIHR Rx & D operating grant (DCT‐49981). Kenneth Rockwood is supported by the Dalhousie Medical Research Foundation as the Kathryn Allen Weldon Professor of Alzheimer Research. DGI Clinical Inc. is supported by the National Research Council of Canada Industrial Research Assistance Program (NRC‐IRAP), the Atlantic Canada Opportunities Agency (ACOA) and Innovacorp. ACADIE was solely sponsored by Pfizer Canada, and VISTA was co‐funded by Janssen‐Ortho Inc and Canadian Institutes of Health Research, through CIHR Rx & D (DCT‐49981).

Publisher Copyright:
© 2020 the Alzheimer's Association

ASJC Scopus Subject Areas

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

PubMed: MeSH publication types

Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1002/alz.12242

Cite this

The Clinician's Interview-Based Impression of Change (Plus caregiver input) and goal attainment in two dementia drug trials: Clinical meaningfulness and the initial treatment response. / Stanley, Justin; Howlett, Susan E.; Dunn, Taylor et al.
In: Alzheimer's and Dementia, Vol. 17, No. 5, 05.2021, p. 856-865.

Research output: Contribution to journal › Article › peer-review

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title = "The Clinician's Interview-Based Impression of Change (Plus caregiver input) and goal attainment in two dementia drug trials: Clinical meaningfulness and the initial treatment response",

abstract = "INTRODUCTION: The Clinician's Interview-Based Impression of Change Plus caregiver input (CIBIC-Plus) has been widely used in dementia drug trials to evaluate cognition, behavior, and function. New trials of symptomatic drugs forecast renewed interest in this measure. METHODS: To test its clinical meaningfulness, we examined how CIBIC-Plus performed in two cholinesterase inhibitor trials compared to goal attainment scaling Scale (GAS) scores, a patient-reported outcome measure. RESULTS: Net goal attainment was seen for all but one GAS domains in subjects who improved on the CIBIC-Plus. Subjects who improved initially on CIBIC-Plus scores were likely to remain improved across all other outcomes for each trial's duration, except for Disability Assessment for Dementia scores. DISCUSSION: The initial response to treatment, as assessed by CIBIC-Plus, remained stable for most outcome measures. Even small CIBIC-Plus improvement changes are associated with clinically meaningful change as assessed by GAS. Other tests detect decline better than improvement.",

author = "Justin Stanley and Howlett, {Susan E.} and Taylor Dunn and Kenneth Rockwood",

note = "Funding Information: ACADIE (1998-1999) was an investigator initiated, open-label clinical trial sponsored by Pfizer Canada. VISTA (2001-2005) was a registered (ISRCTN26167328) peer-reviewed, investigator-initiated, RCT co-funded by Janssen-Ortho Inc. and the Canadian Institutes of Health Research, through a CIHR Rx & D operating grant (DCT-49981). Kenneth Rockwood is supported by the Dalhousie Medical Research Foundation as the Kathryn Allen Weldon Professor of Alzheimer Research. DGI Clinical Inc. is supported by the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP), the Atlantic Canada Opportunities Agency (ACOA) and Innovacorp. ACADIE was solely sponsored by Pfizer Canada, and VISTA was co-funded by Janssen-Ortho Inc and Canadian Institutes of Health Research, through CIHR Rx & D (DCT-49981). Funding Information: ACADIE (1998‐1999) was an investigator initiated, open‐label clinical trial sponsored by Pfizer Canada. VISTA (2001‐2005) was a registered (ISRCTN26167328) peer‐reviewed, investigator‐initiated, RCT co‐funded by Janssen‐Ortho Inc. and the Canadian Institutes of Health Research, through a CIHR Rx & D operating grant (DCT‐49981). Kenneth Rockwood is supported by the Dalhousie Medical Research Foundation as the Kathryn Allen Weldon Professor of Alzheimer Research. DGI Clinical Inc. is supported by the National Research Council of Canada Industrial Research Assistance Program (NRC‐IRAP), the Atlantic Canada Opportunities Agency (ACOA) and Innovacorp. ACADIE was solely sponsored by Pfizer Canada, and VISTA was co‐funded by Janssen‐Ortho Inc and Canadian Institutes of Health Research, through CIHR Rx & D (DCT‐49981). Publisher Copyright: {\textcopyright} 2020 the Alzheimer's Association",

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N2 - INTRODUCTION: The Clinician's Interview-Based Impression of Change Plus caregiver input (CIBIC-Plus) has been widely used in dementia drug trials to evaluate cognition, behavior, and function. New trials of symptomatic drugs forecast renewed interest in this measure. METHODS: To test its clinical meaningfulness, we examined how CIBIC-Plus performed in two cholinesterase inhibitor trials compared to goal attainment scaling Scale (GAS) scores, a patient-reported outcome measure. RESULTS: Net goal attainment was seen for all but one GAS domains in subjects who improved on the CIBIC-Plus. Subjects who improved initially on CIBIC-Plus scores were likely to remain improved across all other outcomes for each trial's duration, except for Disability Assessment for Dementia scores. DISCUSSION: The initial response to treatment, as assessed by CIBIC-Plus, remained stable for most outcome measures. Even small CIBIC-Plus improvement changes are associated with clinically meaningful change as assessed by GAS. Other tests detect decline better than improvement.

AB - INTRODUCTION: The Clinician's Interview-Based Impression of Change Plus caregiver input (CIBIC-Plus) has been widely used in dementia drug trials to evaluate cognition, behavior, and function. New trials of symptomatic drugs forecast renewed interest in this measure. METHODS: To test its clinical meaningfulness, we examined how CIBIC-Plus performed in two cholinesterase inhibitor trials compared to goal attainment scaling Scale (GAS) scores, a patient-reported outcome measure. RESULTS: Net goal attainment was seen for all but one GAS domains in subjects who improved on the CIBIC-Plus. Subjects who improved initially on CIBIC-Plus scores were likely to remain improved across all other outcomes for each trial's duration, except for Disability Assessment for Dementia scores. DISCUSSION: The initial response to treatment, as assessed by CIBIC-Plus, remained stable for most outcome measures. Even small CIBIC-Plus improvement changes are associated with clinically meaningful change as assessed by GAS. Other tests detect decline better than improvement.

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The Clinician's Interview-Based Impression of Change (Plus caregiver input) and goal attainment in two dementia drug trials: Clinical meaningfulness and the initial treatment response

Abstract

Bibliographical note

ASJC Scopus Subject Areas

PubMed: MeSH publication types

UN SDGs

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