ArticleAlzheimer's & dementia : the journal of the Alzheimer's Association2024
Care partner-informed meaningful change thresholds for the Clinical Dementia Rating-Sum of Boxes for trials of early Alzheimer's disease.
Article in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03289143 (A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients With Prodromal to Mild Alzheimer's Disease), which is not on this map. Cited by 13 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients With Prodromal to Mild Alzheimer's Disease
Who cites it
13 citing papers in PubMed.
- miR-214-3p and NCKAP1: A microglial functional dimension of Alzheimer's progression.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Article
- Anti-Amyloid Antibodies in the Treatment of Alzheimer's Disease: An Umbrella Review.Journal of clinical medicine · 2026Review
- Priorities of people living with Alzheimer's and care partners: What Matters Most?Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Observational
- The Centiloid Scale in Amyloid PET Imaging: Current Role in Alzheimer's Disease Diagnosis, Treatment Planning, and Monitoring During Anti-Amyloid Therapy: A Clinical Perspective.Diagnostics (Basel, Switzerland) · 2026Review
- Validity of the two different scoring methods of the Clinical Dementia Rating scale in staging and detection of cognitive impairment in the Peruvian population.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Article
- Meaningful within-person change estimates do not identify responders to treatment.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Article
- Systemic inflammation, delirium and clinical progression in mild-moderate Alzheimer disease.EBioMedicine · 2026Article
- Physical activity as a modifiable risk factor in preclinical Alzheimer's disease.Nature medicine · 2025Article
- Appropriate use of meaningful within-patient change (MWPC) thresholds in Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Article
- Care partner-informed meaningful change thresholds for the Clinical Dementia Rating-Sum of Boxes for trials of early Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2024Article
- Clinical Meaningfulness in Alzheimer's Disease Clinical Trials. A Report from the EU-US CTAD Task Force.The journal of prevention of Alzheimer's disease · 2024Article
- Perspective: Minimal clinically important difference (MCID) and Alzheimer's disease clinical trials.Alzheimer's & dementia (New York, N. Y.)Article
- How do we put meaning into meaningful benefit? Perspectives from the lived experience.Alzheimer's & dementia (New York, N. Y.)Article
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Authors and funding
8 authors.
Funding
Abstract
introductionConsensus 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.
methodsAnchor-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.
resultsAcross 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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