Rationale for use of the Clinical Dementia Rating Sum of Boxes as a primary outcome measure for Alzheimer's disease clinical trials

Cedarbaum, Jesse M.; Jaros, Mark; Hernandez, Chito; Coley, Nicola; Andrieu, Sandrine; Grundman, Michael; Vellas, Bruno

doi:10.1016/j.jalz.2011.11.002

Cited by 115 publications

(136 citation statements)

References 30 publications

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“…The correlations shown between change in the CDR-SB and change in the MMSE and IADL are in agreement with two other studies with similar design [3,4]. Notably, the correlations were stronger between CDR-SB and IADL than between CDR-SB and MMSE.…”

Section: Discussionsupporting

confidence: 91%

“…Spearman correlation coefficients were calculated to compare these changes. Based on factor analyses from other studies of CDR-SB [3,4], we also divided CDR-SB into "cognitive" and "functional" subscores. The cognitive subscore included the first three items (memory, orientation, and judgment) and the functional subscore the last three (community activities, home and hobbies, and personal care).…”

Section: Statisticsmentioning

confidence: 99%

“…A mean yearly change in CDR-SB between 1.4 and 2.3 points is reported for patients with AD. Disease progression in AD is generally described as slower in the initial stages than in a more advanced stage of the disease, with yearly progression in CDR-SB of 0.5 to 1.9 points among patients with amnestic MCI (aMCI) or very mild dementia (CDR 0.5) and 1.3 to 1.9 points among patients with mild dementia (CDR 1) [3][4][5][6]. There is considerable individual variation in progression rates [7,8].…”

Section: Introductionmentioning

confidence: 99%

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Progression of Alzheimer’s Disease: A Longitudinal Study in Norwegian Memory Clinics

Eldholm

Barca

Persson

et al. 2018

JAD

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Abstract.Background: The course of Alzheimer's disease (AD) varies considerably between individuals. There is limited evidence on factors important for disease progression. Objective: The primary aim was to study the progression of AD, as measured by the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB). Secondary aims were to investigate whether baseline characteristics are important for differences in progression, and to examine the correlation between progression assessed using three different instruments: CDR-SB (0-18), the cognitive test Mini-Mental State Examination (MMSE, 0-30), and the functional measure Instrumental Activities of Daily Living (IADL, 0-1). Methods: The Progression of AD and Resource use (PADR) study is a longitudinal observational study in three Norwegian memory clinics. Results: In total, 282 AD patients (mean age 73.3 years, 54% female) were followed for mean 24 (16-37) months. The mean annual increase in CDR-SB was 1.6 (SD 1.8), the mean decrease in MMSE score 1.9 (SD 2.6), and the mean decrease in IADL score 0.13 (SD 0.14). Of the 282 patients, 132 (46.8%) progressed slowly, with less than 1 point yearly increase in CDR-SB. Cognitive test results at baseline predicted progression rate, and together with age, ApoE, history of hypertension, and drug use could explain 17% of the variance in progression rate. The strongest correlation of change was found between CDR-SB and IADL scores, the weakest between MMSE and IADL scores.

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Section: Discussionsupporting

confidence: 91%

Section: Statisticsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Progression of Alzheimer’s Disease: A Longitudinal Study in Norwegian Memory Clinics

Eldholm

Barca

Persson

et al. 2018

JAD

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“…The aim of the clinical diagnosis for some dementia (as a frontal) is not the memory impairment on the acute phase (Pirani et al 2010). CDR is used to assess three domains of cognition (memory, orientation, problem solving) and functions (community affairs, home and hobbies, personal care) (Cedarbaum et al 2013). All LA individuals had an overall CDR of 0.5 or over 0.5.…”

Section: Clinical Dementia Rating (Cdr) Scalementioning

confidence: 99%

Carotid Artery Stenting Ameliorates the Cognitive Impairment in Patients with Leukoaraiosis, the Ischemic Change of Cerebral White Matter

Sun

Xia

et al. 2014

Tohoku J. Exp. Med.

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Leukoaraiosis (LA) is a leading cause of gait disturbance in the elderly and well known as a type of cerebrovascular diseases. LA is mainly caused by the focal ischemic damage in cerebral white matter. Cognitive impairment in patients with LA is difficult to treat. Carotid artery stenting (CAS) has been reported to improve the cognitive function in patients with cognitive impairment. However, whether CAS can ameliorate the cognitive impairment in patients with LA remains unknown. To address this problem, we prospectively enrolled 105 LA patients with carotid stenosis and 206 healthy subjects, who are free of carotid artery stenosis and brain diseases or injuries, as the control. Neuropsychological functions were tested in these LA patients before and after 1-, 6-and 12-month CAS, and compared with the data of control subjects. Mini-Mental State Examination (MMSE) and Wechsler Adult Intelligence Scale-Revised China (WAIS-RC) scores were lower in LA patients than those in healthy controls (P < 0.05), indicating the cognitive impairment in the LA patients. Compared with the scores before CAS, there is a time-dependent increase in MMSE and WAIS-RC scores after 1-, 6-and 12-month CAS (P < 0.05). Moreover, CAS treatment reduced Clinical Dementia Rating scale in LA patients. The cognitive impairment of LA patients with carotid stenosis was severe, but their cognitive impairment was ameliorated with carotid stenosis (P < 0.01). Thus, CAS can improve cognitive function of the LA patients with carotid stenosis.

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“…The use of time to progression from mild cognitive impairment to AD dementia as a primary outcome measure in RCTs for putative disease-modifying drugs in AD is problematic owing to inherent shortcomings, which include requisite large sample sizes and reliance on a centralized adjudication committee [1]. Similarly, use of currently available cognitive assessment metrics, such as the Alzheimer's Disease Assessment Scale - cognitive subscale, lack sensitivity in the early stages of AD and are associated with variable rates of change [2,3].…”

Section: Trial Designs Outcomes and Biomarkers In Rcts For Disease-mmentioning

confidence: 99%

How Can We Improve Transfer of Outcomes from Randomized Clinical Trials to Clinical Practice with Disease-Modifying Drugs in Alzheimer's Disease?

Gauthier¹,

Leuzy²,

Rosa‐Neto³

2013

Neurodegener Dis

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Background: Randomized clinical trials (RCTs) for putative disease-modifying drugs in Alzheimer's disease (AD) are using cognitive outcomes, such as the Alzheimer's Disease Assessment Scale - cognitive subscale, activities of daily living scales, such as the Alzheimer's Disease Cooperative Study Activities of Daily Living, and time from mild cognitive impairment to AD dementia. Objective: It was the aim of this study to build clinically relevant outcomes for future use in clinical practice into RCT designs and help third-party payers to measure benefit. Methods: We used a literature review for analysis. Results: The Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) appears to be the most reliable primary outcome for RCT at different stages of AD, with the Relevant Outcome Scale for Alzheimer's Disease (ROSA) as a suitable alternative. The importance of current AD biomarkers vis-à- vis determination of efficacy of disease-modifying drugs has yet to be established; however, it is likely that at least one amyloid-specific test will be required prior to treatment with a drug acting predominantly on β-amyloid (Aβ42). Furthermore, serial MRI may be required to monitor adverse side effects associated with such drugs. Conclusions: Global clinical scales such as CDR-SB and ROSA should be considered for use with treatments aiming at slowing disease progression.

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Rationale for use of the Clinical Dementia Rating Sum of Boxes as a primary outcome measure for Alzheimer's disease clinical trials

Abstract: The CDR-SB has psychometric properties that make it attractive as a primary outcome measure that comprehensively assesses both cognitive and functional disability in AD patients. It may prove particularly useful for studies in early, predementia stages of AD.

Cited by 115 publications

References 30 publications

Progression of Alzheimer’s Disease: A Longitudinal Study in Norwegian Memory Clinics

Progression of Alzheimer’s Disease: A Longitudinal Study in Norwegian Memory Clinics

Carotid Artery Stenting Ameliorates the Cognitive Impairment in Patients with Leukoaraiosis, the Ischemic Change of Cerebral White Matter

How Can We Improve Transfer of Outcomes from Randomized Clinical Trials to Clinical Practice with Disease-Modifying Drugs in Alzheimer's Disease?

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