Enrichment of clinical trials in MCI due to AD using markers of amyloid and neurodegeneration.
Neurology
; 87(12): 1235-41, 2016 Sep 20.
Article
em En
| MEDLINE
| ID: mdl-27558378
ABSTRACT
OBJECTIVE:
To investigate the effect of enriching mild cognitive impairment (MCI) clinical trials using combined markers of amyloid pathology and neurodegeneration.METHODS:
We evaluate an implementation of the recent National Institute for Aging-Alzheimer's Association (NIA-AA) diagnostic criteria for MCI due to Alzheimer disease (AD) as inclusion criteria in clinical trials and assess the effect of enrichment with amyloid (A+), neurodegeneration (N+), and their combination (A+N+) on the rate of clinical progression, required sample sizes, and estimates of trial time and cost.RESULTS:
Enrichment based on an individual marker (A+ or N+) substantially improves all assessed trial characteristics. Combined enrichment (A+N+) further improves these results with a reduction in required sample sizes by 45% to 60%, depending on the endpoint.CONCLUSIONS:
Operationalizing the NIA-AA diagnostic criteria for clinical trial screening has the potential to substantially improve the statistical power of trials in MCI due to AD by identifying a more rapidly progressing patient population.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Encéfalo
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Ensaios Clínicos como Assunto
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Peptídeos beta-Amiloides
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Doença de Alzheimer
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Disfunção Cognitiva
Tipo de estudo:
Etiology_studies
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Incidence_studies
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Aged
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Female
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Humans
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Male
Idioma:
En
Ano de publicação:
2016
Tipo de documento:
Article