Initiation of symptomatic medication in Alzheimer's disease clinical trials: Hypothetical versus treatment policy approach.
Alzheimers Dement
; 16(5): 797-803, 2020 05.
Article
em En
| MEDLINE
| ID: mdl-32270600
ABSTRACT
In clinical trials in populations with mild cognitive impairment, it is common for participants to initiate concurrent symptomatic medications for Alzheimer's disease after randomization to the experimental therapy. One strategy for addressing this occurrence is to exclude any observations that occur after the concurrent medication is initiated. The rationale for this approach is that these observations might reflect a symptomatic benefit of the concurrent medication that would adversely bias efficacy estimates for an effective experimental therapy. We interrogate the assumptions underlying such an approach by estimating the effect of newly prescribed concurrent medications in an observational study, the Alzheimer's Disease Neuroimaging Initiative.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Progressão da Doença
/
Doença de Alzheimer
/
Disfunção Cognitiva
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
/
Observational_studies
Limite:
Aged
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
Alzheimers Dement
Ano de publicação:
2020
Tipo de documento:
Article