FLAME: A computerized neuropsychological composite for trials in early dementia
| Autor: | José Luis Molinuevo, Keith Wesnes, Helen Brooker, Clive Ballard, Anne Corbett, Jeffrey L. Cummings, Dag Aarsland, Charlotte Thim-Hansen, Tormod Fladby, Alireza Atri, Adam Hampshire, Byron Creese, Gareth Williams, Zahinoor Ismail |
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| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Disease lcsh:Geriatrics lcsh:RC346-429 03 medical and health sciences 0302 clinical medicine Physical medicine and rehabilitation Normal cognition medicine Sensitivity to change lcsh:Neurology. Diseases of the nervous system 030304 developmental biology 0303 health sciences clinical trials business.industry Neuropsychology Cognition Alzheimer's MCI sample size Clinical trial Psychiatry and Mental health lcsh:RC952-954.6 Sample size determination PROTECT Early dementia Cognitive & Behavioral Assessment Neurology (clinical) business early dementia 030217 neurology & neurosurgery Research Article |
| Zdroj: | Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring, Vol 12, Iss 1, Pp n/a-n/a (2020) Alzheimer's & Dementia : Diagnosis, Assessment & Disease Monitoring |
| ISSN: | 2352-8729 |
| Popis: | Introduction Sensitive neuropsychological tests are needed to improve power for clinical trials in early Alzheimer's disease (AD). Methods To develop a neuropsychological composite (FLAME – Factors of Longitudinal Attention, Memory and Executive Function), we assessed, 10,714 participants over the age of 50 from PROTECT with validated computerized assessments for 2 years. A factorial analysis was completed to identify the key cognitive factors in all participants, and further analyses examined sensitivity to change in people with stage 2/3 early Alzheimer's disease (AD) according to the US Food and Drug Administration (FDA) framework. Results The FLAME composite score (speed of attention, accuracy of attention, memory, and executive function) distinguished between normal cognition and stage 2/3 early AD at baseline, and was sensitive to cognitive and global/functional decline over 2 years, with the potential to improve power for clinical trials. Discussion FLAME is sensitive to change, providing a straightforward approach to reduce sample size for RCTs in early AD. Conclusion FLAME is a useful computerized neuropsychology composite with utility for clinical trials focusing on cognition. |
| Databáze: | OpenAIRE |
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