Abstract
INTRODUCTION
Consensus definitions of meaningful within-patient change (MWPC) on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) are needed. Existing estimates use clinician-rated anchors in clinically diagnosed Alzheimer’s disease (AD) populations. Incorporating the care partner perspective offers important insights, and evaluating biomarker-confirmed cohorts aligns estimates with ongoing trials.
METHODS
Anchor-based analyses were conducted to evaluate MWPC on the CDR-SB in early AD (Tauriel; NCT03289143) using Caregiver Global Impression of Change in memory or daily activities.
RESULTS
Across time points and anchors, mean CDR-SB changes associated with the “somewhat worse” category ranged from 1.50 to 2.12 in early AD, 1.07 to 2.06 in mild cognitive impairment-AD, and 1.79 to 2.25 in mild AD.
DISCUSSION
The proposed ranges are appropriate to define meaningful progression on the CDR-SB in similar cohorts and support the interpretation of treatment benefit through MWPC analyses. Thresholds should be calibrated to the context of use; lower/higher thresholds may be applicable in studies of earlier/later disease over shorter/longer durations.
Highlights
Within-patient CDR-SB change thresholds are provided using caregiver-rated anchors.
1.5 to 2.5 points may be an appropriate range in early AD trials of similar durations.
Cumulative distribution function plots illustrate the benefit of a given treatment.
When selecting thresholds, the target population and study design should be considered.
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This post is Copyright: Claire J. Lansdall,
Edmond Teng,
Jerome Chague,
Rohan Palanganda,
Paul Delmar,
Janice Smith,
Jeffrey L. Cummings,
Fiona McDougall | July 17, 2024