Establishing Clinically Meaningful Change on Outcome Assessments Frequently Used in Trials of Mild Cognitive Impairment Due to Alzheimer’s Disease - 21/11/24
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Abstract |
Background |
Consensus is lacking on what constitutes a meaningful score change for individual patients on clinical outcome assessments (COAs) that are commonly used in clinical trials of Alzheimer’s disease. Such thresholds are one important approach to help contextualize trial results and demonstrate meaningful treatment benefit.
Objectives |
To estimate meaningful within-patient change thresholds for the Clinical Dementia Rating Scale — Sum of Boxes (CDR-SB), Alzheimer’s Disease Assessment Scale — Cognitive Subscale (ADAS-Cog), and the Mini-Mental State Examination (MMSE) among participants with mild cognitive impairment (MCI).
Design |
Retrospective anchor- and distribution-based analyses of data from the ADC-008 (NCT00000173) study were used to estimate thresholds for meaningful within-patient change on the target measures.
Setting |
Analyses were conducted using data from ADC-008 a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study among participants with the amnestic subtype of MCI, which was conducted by the Alzheimer’s Disease Cooperative Study (ADCS) between March 1999 and January 2004 in the United States and Canada.
Participants |
Analyses were based on 769 eligible participants who completed the baseline assessment from 69 ADCS sites in the United States and Canada.
Measurements |
The target outcome measures for this analysis included the CDR-SB, the ADAS-Cog, and the MMSE. The anchor measures for this analysis included the Global Deterioration Scale and the MCI—Clinical Global Impression of Change.
Results |
Focusing on the 12-month time point, within-patient increases of 1–2.5 points in the CDR-SB and increases of 2–5 points on the 11-item ADAS-Cog and 13-item ADAS-Cog, on average, reflect minimal-to-moderate levels of deterioration, respectively.
Conclusions |
These thresholds may be useful to aid the interpretation of Alzheimer’s disease clinical trial data by illustrating meaningful within-patient progression over the course of a clinical trial via supplementary progressor analyses, which may in turn be informative for treatment decisions. Estimates generated via these methods are specifically intended to evaluate within-patient change and are not intended to assess the magnitude and meaningfulness of differences between group-level changes over time.
El texto completo de este artículo está disponible en PDF.Key words : Alzheimer’s disease, clinical outcome assessment, endpoint, mild cognitive impairment, meaningful change, clinically important, ADC-008
Esquema
| Data Sharing: For eligible studies qualified researchers may request access to individual patient level clinical data through a data request platform. At the time of writing this request platform is Vivli. roche/. For up to date details on Roche’s Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here: data_sharing. Anonymised records for individual patients across more than one data source external to Roche can not, and should not, be linked due to a potential increase in risk of patient re-identification. |
Vol 10 - N° 1
P. 9-18 - janvier 2023 Regresar al número
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