Nicola Coley1, Adeline Gallini2, Pierre-Jean Ousset3, Bruno Vellas3, Sandrine Andrieu2. 1. INSERM-University of Toulouse, UMR1027, Toulouse, France; Department of Epidemiology and Public Health, CHU Toulouse, Toulouse, France. Electronic address: nicola.coley@inserm.fr. 2. INSERM-University of Toulouse, UMR1027, Toulouse, France; Department of Epidemiology and Public Health, CHU Toulouse, Toulouse, France. 3. INSERM-University of Toulouse, UMR1027, Toulouse, France; Department of Geriatric Medicine, CHU Toulouse, Gerontopole, Toulouse, France.
Abstract
INTRODUCTION: Composite cognitive scores have been developed as primary outcome measures for preclinical/prevention trials for Alzheimer's disease (AD), mainly using observational data and with little consideration of clinical relevance. METHODS: Secondary analysis of placebo group data from a 5-year AD prevention trial. The composite score was the average of the following z scores: MMSE orientation items, Free and Cued Selective Reminding Test, Category Fluency, Trail Making Test-part B. RESULTS:Composite score change from baseline differed significantly by age, APOE genotype, and CDR progression and AD dementia status. A 1 point decrease in baseline score was highly predictive of 5-year AD dementia risk (HR = 3.51, 95% CI, 2.62-4.71, P < .001). The 1 year minimum clinically important difference was estimated at -0.3 points and predicted AD dementia. DISCUSSION: We explored the clinical relevance of a composite score in a prevention trial setting. This type of analysis facilitates the interpretation of composite scores and informs power calculations.
RCT Entities:
INTRODUCTION: Composite cognitive scores have been developed as primary outcome measures for preclinical/prevention trials for Alzheimer's disease (AD), mainly using observational data and with little consideration of clinical relevance. METHODS: Secondary analysis of placebo group data from a 5-year AD prevention trial. The composite score was the average of the following z scores: MMSE orientation items, Free and Cued Selective Reminding Test, Category Fluency, Trail Making Test-part B. RESULTS: Composite score change from baseline differed significantly by age, APOE genotype, and CDR progression and AD dementia status. A 1 point decrease in baseline score was highly predictive of 5-year AD dementia risk (HR = 3.51, 95% CI, 2.62-4.71, P < .001). The 1 year minimum clinically important difference was estimated at -0.3 points and predicted AD dementia. DISCUSSION: We explored the clinical relevance of a composite score in a prevention trial setting. This type of analysis facilitates the interpretation of composite scores and informs power calculations.
Authors: Roos J Jutten; John Harrison; Frank Jan de Jong; André Aleman; Craig W Ritchie; Philip Scheltens; Sietske A M Sikkes Journal: Alzheimers Dement (N Y) Date: 2017-02-09
Authors: Stefan J Teipel; Chimezie O Amaefule; Stefan Lüdtke; Doreen Görß; Sofia Faraza; Sven Bruhn; Thomas Kirste Journal: Front Psychol Date: 2022-04-25
Authors: Jasmine Tan; F H Maurine Tsakok; Elisabeth K Ow; Bernard Lanskey; Kian Siong Darius Lim; Lee Gan Goh; Chay-Hoon Tan; Irwin Kee-Mun Cheah; Anis Larbi; Roger Foo; Marie Loh; Caroline Kai Yun Wong; John Suckling; Jialiang Li; Rathi Mahendran; Ee-Heok Kua; Lei Feng Journal: Front Aging Neurosci Date: 2018-07-10 Impact factor: 5.750