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Articles by Nicola Coley
Total Records ( 2 ) for Nicola Coley
  Sophie Gillette- Guyonnet , Sandrine Andrieu , Fati Nourhashemi , Virginie Gardette , Nicola Coley , Christelle Cantet , Serge Gauthier , Pierre-Jean Ousset and Bruno Vellas
  Background Patients with Alzheimer‘s disease (AD), even in the presence of symptomatic relief from medical intervention, face a persistent worsening of cognitive decline and performance in activities of daily living. Data regarding the long-term disease progression outside of therapeutic trials are lacking. We examined the effects of standard of care for AD patients on the prognosis of the disease in a real-life study over a 4-year period. Methods A total of 686 patients with mild-moderate AD were enrolled in 16 memory clinics (REseau sur la maladie d‘ Alzheimer FRancais [REAL.FR] cohort) and followed up twice annually with tools used in therapeutic trials (Mini-Mental Status Examination, Alzheimer Disease Assessment Scale-cognitive subscale [ADAS-cog]: cognitive function, Clinical Dementia Rating: dementia severity, Activity of Daily Living [ADL]: incapacities, NeuroPsychiatric Inventory: neuropsychiatric symptom). Results More than 90% of the patients used AD-specific medication over 4 years. Patients lost on average 2.4 points per year on the Mini-Mental Status Examination and gained 4.5 points on the ADAS-cog. ADL and NeuroPsychiatric Inventory scores became significantly worse over time. Incidence of incapacities for ADL and worsening of neuropsychiatric symptoms were 52.5 (95% confidence interval [CI]: 47.7–57.4) and 51.1 (95% CI: 46.2–56.1), respectively. Rates of mortality and institutionalization were 7.4 (95% CI: 6.2–8.5) and 13.4 (95% CI: 11.7–15.1). In all, 17% of patients in mild stage at baseline (Clinical Dementia Rating = 0.5) did not experience a major event (functional disabilities, neuropsychiatric symptoms, or death) over a 4-year period. Conclusions As compared with previous surveys, the current study shows slower rates of decline in AD patients. The present data also underline the high level of variability of disease progression among AD patients. Outcome measures commonly used in clinical trials will need to take into account the recent changes in the prognosis of the disease.
  Nicola Coley , Sandrine Andrieu , Mark Jaros , Michael Weiner , Jesse Cedarbaum and Bruno Vellas
  Background Clinical measures continue to be used as primary endpoints for disease-modifying trials for Alzheimer‘s disease (AD). Currently, two co-primary endpoints must be specified, which measure cognitive and functional impairments. Generally, the Alzheimer‘s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is one of the co-primary endpoints, but high variability in this measure results in large sample sizes. We evaluated the psychometric properties of the Clinical Dementia Rating-Sum of Boxes (CDR-SB) to assess its suitability as a single primary endpoint as an alternative to the traditional co-primary approach. Methods Internal consistency, structural and convergent validity, and 2-year internal and external responsiveness of the CDR-SB were assessed in 667 very mild to moderate (global Clinical Dementia Rating, 0.5–2) AD patients from the REAL.FR (Reseau sur la Maladie d'Alzheimer Francais) study. Results The CDR-SB showed good internal consistency (Cronbach‘s alpha = 0.88), and acceptable structural (separate ”cognitive“ and ”functional“ factors) and convergent validity. Variability in mean changes over time was low, leading to excellent internal responsiveness (effect size = 1.2; standardized response mean = 1.17 at 2 years) and smaller sample sizes as compared with the ADAS-Cog. External responsiveness was acceptable when compared with ”clinically meaningful“ changes on the Activities of Daily Living scale but only borderline acceptable when compared with the ADAS-Cog and Instrumental Activities of Daily Living. Levels of missing data and floor/ceiling effects were low. Conclusions The CDR-SB measures cognitive and functional impairment simultaneously, and has excellent 2-year internal responsiveness. This makes it a promising candidate as a sole primary endpoint for AD trials, although more work is required to determine the clinical relevance of CDR-SB changes, and its usefulness as an endpoint at other disease stages.
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