Quantifying placebo responses in clinical evaluation of neuropsychiatric symptoms in Alzheimer’s disease View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2019-04

AUTHORS

Ningyuan Zhang, Yinghua Lv, Huafang Li, Junchao Chen, Yunfei Li, Fang Yin, Lujin Li, Qingshan Zheng

ABSTRACT

PURPOSE: This study aimed to establish a non-linear mixed effects model to quantitatively analyze the placebo responses of neuropsychiatric symptoms (NPS) in Alzheimer's disease (AD). METHODS: A comprehensive literature search was conducted in public databases. Placebo-controlled randomized AD clinical trials using the neuropsychiatric inventory (NPI) score as the primary or secondary outcome were included. Non-linear mixed effects model was used to describe the time course of the placebo responses of NPS in AD clinical trials. Potential affecting factors were tested as covariates. RESULTS: A total of 32 clinical studies (involving 3942 subjects) were included in model-based analysis. We found that the maximal placebo responses of NPS were reached at week 4 approximately, after which rebound effects appeared. The baseline NPI score had a significant impact on the placebo responses. Higher baseline NPI score tended to cause greater reductions in NPI score at week 8 and a smaller degree of rebound. For AD patients whose normalized baseline NPI score was 10 points and 30 points, the reduction in normalized NPI score at week 8 was estimated to be 0.83 and 7.43 points, respectively; and the rebound rate after week 8 was estimated to be 0.1 points/week and 0.08 points/week, respectively. CONCLUSIONS: The duration of 4 weeks is sufficient to determine the drug efficacy for assessing NPS in AD clinical trials. The baseline NPI score was a key factor associated with placebo responses of NPS, which should be considered when designing future clinical trials and conducting comparisons across trials. More... »

PAGES

497-509

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00228-018-02620-x

DOI

http://dx.doi.org/10.1007/s00228-018-02620-x

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1111157092

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30612155


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