Open Access. Powered by Scholars. Published by Universities.®
Psychiatric and Mental Health Commons™
Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 2 of 2
Full-Text Articles in Psychiatric and Mental Health
Regulatory Implications Of Inadequately Designed Pimavanserin Drug Trials Published With Risk Of Bias On Expedited Regulatory Approval Processes, Benson Law
Electronic Thesis and Dissertation Repository
The objective of this retrospective critical appraisal study was to determine if the trials submitted to the Food and Drug Administration for the expedited approval of pimavanserin was of sufficient methodological quality to ascertain its safety and efficacy. After the general metrics of the trials were assessed, the Risk of Bias 2 tool and the PRagmatic Explanatory Continuum Indicator Summary tool were employed to evaluate the risk of bias and the design suitability of the trials. This study suggests that the decision to approve pimavanserin for the treatment of Parkinson’s Disease Psychosis failed to meet the threshold of evidence normally …
White Matter Inflammation And Executive Dysfunction: Implications For Alzheimer Disease And Vascular Cognitive Impairment, Alexander Levit
White Matter Inflammation And Executive Dysfunction: Implications For Alzheimer Disease And Vascular Cognitive Impairment, Alexander Levit
Electronic Thesis and Dissertation Repository
White matter integrity is crucial to healthy executive function, the cognitive domain that enables functional independence. However, in the ageing brain, white matter is highly vulnerable. White matter inflammation increases with age and Alzheimer disease (AD), which disrupts the normal function of white matter. This may contribute to executive dysfunction, but the relationship between white matter inflammation and executive function has not been directly evaluated in ageing nor AD. White matter is also particularly vulnerable to cerebrovascular disease, corresponding with the common presentation of executive dysfunction in vascular cognitive impairment (VCI). Thus, white matter may be an important substrate by …